Pharmacovigilance MSc

About the course

1/

The aim of this MSc is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines, handling safety issues including labelling and risk management and systems and processes. Teaching consists of lectures and workshop activities in small groups and takes into account real world situations. There are opportunities for sharing experiences and networking which contributes to the development of your knowledge and understanding of pharmacovigilance issues.

This is a flexible programme designed to meet the needs of those in either full or part-time employment who are likely to have a spread of responsibilities. Participants will normally be graduates and/or experienced personnel and usually will need to have held positions in drug safety for one to several years. The programme is run as a series of intensive short courses supplemented with substantial pre and post-course reading and set coursework. In addition, if you are studying for an MSc, you will undertake a research project that is normally carried out at your workplace but may be done at the University, or an institution with appropriate experience of pharmacovigilance or adverse drug reactions.

The programme has attracted students from European Union countries, Norway, Switzerland, Japan and the USA and its success has led to the organisation of an annual Pharmacovigilance Update day for those who have completed their studies.

Recruitment will take place at the beginning of each taught module and the programme offers the awards of a PgC, PgD or MSc. You will be able to obtain any one of the awards in a minimum of two years; however registration for up to five years is permissible within the programme.

Download the MSc Pharmacovigilance brochure

Why choose this course?

  • The MSc/PgD/PgC in Pharmacovigilance is a programme developed by the School of Life and Medical Sciences and the Pharmaceutical Information and Pharmacovigilance Association (PIPA).
  • In addition to offering this course, The University of Hertfordshire is also part of the Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, an online pan European e-learning/e-teaching MSc course.
  • The programme includes eight taught modules, provided as intensive three-day workshops, and for the MSc award, a research project.
  • It is taught mainly through teams of staff drawn from the professions appropriate to pharmacovigilance. This is a major feature of the programme, the majority of staff delivering the courses will be acknowledged experts.
  • The aim is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines, handling safety issues and the role of systems and processes.

Entry requirements...

  • A first or second class Honours degree in Biosciences, Pharmacy or Biological Chemistry
  • Or a professional qualification accepted as equivalent to the above
  • Or a qualification in veterinary science, medicine or dentistry
  • Or a first or second class Honours degree in disciplines that would be judged as equivalent to the above

Plus at least 6 months' experience in full-time Pharmacovigilance work and proficiency in English as demonstrated by an approved test e.g. ILETS score 7.0, if English is not the first language.

Applicants not within the categories described above, but who can demonstrate by other qualifications, research publications or appropriate experience that they can succeed on the course will be considered on individual merit.

Study routes

  • Part Time, 5 Years

Locations

  • University of Hertfordshire, Hatfield

Careers

Potential candidates will normally be in either full or part-time employment and are likely to have a spread of responsibilities, mostly in pharmacovigilance and medical information, monitoring safety data in either pre- and post-marketing studies or from spontaneous reports. They will be graduates and/or experienced personnel and usually will have held positions in drug safety for one to several years. Some applicants may have doctorates and may be medically qualified. Following successful completion of the course the knowledge gained should enable the post-graduates to make a greater contribution to the pharmacovigilance industry.

Teaching methods

Taught modules normally consist of approximately 24 hours class contact. In addition, about 120 hours will be needed to complete the pre and post-course activities. The actual amount of time spent will depend upon your existing knowledge and ability. All modules are free-standing. Satisfactory completion of four modules is compulsory for the PgCert; all eight modules are required for the PgDip and MSc. Coursework will contribute significantly to assessment and may comprise some or all of the following: summaries of pre-course reading, written reports of class discussions, essays, performances in seminars, poster presentations, problem solving or data interpretation exercise, short projects and case studies. Unseen written examinations will feature in some courses; they may be used to examine understanding of pre-course reading material. Attendance at the taught component and satisfactory completion of both coursework and examinations (where present), with a minimum mark of 50% in each element, is normally required to pass each module.

Professional Accreditations

PIPA (Pharmaceutical Information and Pharmacovigilance Association)

Structure

Year 1

Core Modules

Optional

  • Adverse Drug Reactions by Major Body Systems

    Basic statistical significance tests, Classification of ADRs, Pharmacokinetics (ADME), pharmaceutical, pharmacokinetic, pharmacodynamic and pharmacogenetic factors leading to ADRs, Physiological control systems. The adverse effect of drugs on the immune, respiratory, cardiovascular, central nervous, haematological, renal and hepatic systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Criteria for defining ADRs. Exercises to evaluate cases and how these can be determined.

  • Adverse Drug Reactions by Major Body Systems I

  • Adverse Drug Reactions by Major Body Systems II

    The adverse effect of drugs on the renal, cutaneous, gastrointestinal, musculoskeletal, and endocrine systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Drug interactions: pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples. Drug administration in pregnancy: stages in foetal development and sensitivity to teratogens and other toxic effects on foetal tissue. Use of drugs in nursing mothers: effects on lactation, infant toxicity, relevance of animal toxicology data. Other special groups including: drug use in paediatric patients, the elderly and those with hepatic and renal impairment. Drug overdoses - Poisons Information Centres. Lack of efficacy and Off-label use (GVP VI). Reference to Periodic Safety Update Reports (GVP VII) and Post-authorisation safety studies (GVP VIII).

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials; phases of clinical trials, trial design and analysis; adverse event reporting and monitoring in clinical trials; protocol development and case record form design; GCP; exercise on protocol design and safety monitoring aspects of a study; safety issues in clinical pharmacology studies; ethics committees; randomisation and the breaking of study codes; investigator brochures; presentation of safety data from clinical trials - study reports, (EU Clinical Trials Directive, Quarterly and Annual Safety Reports,FDA Investigational New Drug Safety reports and Annual Reports), MAAs; NDAs, SPC; large scale endpoint studies and Safety Monitoring Boards; statistical considerations; exercise on interpretation and presentation of safety data; laboratory data: meaning, analysis and presentation; role of Clinical Research Organisations and safety; limitations of clinical trials in determining the safety profile of a new medicine.

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials. Phases of clinical trials: trial design and analysis (including adaptive design), adverse event reporting and monitoring in clinical trials, protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP), protocol design and safety monitoring aspects of a study, safety biomarkers, safety issues in clinical pharmacology studies, ethics committees; randomisation and the breaking of study codes. Investigator brochures; presentation of safety data from clinical trials; study reports; product licence applications format and organisation of the CTD clinical summaries (ini particular the SCS) as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials in determining the safety profile of a new medicine. Statistics. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products (including concepts of IMP, non-IMP). Investigator notifications (IND). Management of urgent safety measures.

  • Labelling and Risk Management

  • Management of Pharmacovigilance Data

    Information Systems and Compliance Use of SOPs, working practices & guidelines in data management. Auditing, quality assurance & inspections. Pharmacovigilance Databases Database design (vendor & bespoke systems), customisation, implementation and validation (relevant regulations including data privacy). Maintenance of company systems & upgrades. Coding (medical terminology, products and lists of values) Medical terminology including updates. Products and coding).Pharmacovigilance data values. Electronic Reporting and Safety Data Exchange Interaction with agencies, seeking information and for electronic interchange. Global electronic reporting of individual case safety reports. Safety data exchange procedures inter- and intra-companies. Risk Management Safety data in decision making; management of identified and potential risks. Practical risk management including effective communication. Signal Detection and Data Mining Use of adverse experience and prescription data to determine signals. Statistical methods for signal detection; data mining.

  • Management of Pharmacovigilance Data

    Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data (methods used for collection and follow-up). Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, auditing, quality assurance and inspections. PV Databases: Database design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Coding (medical terminology, products and lists of values), PV data values. Electronic Reporting and Safety Data Exchange: Interaction with agencies for seeking information and for electronic interchange, global electronic reporting of individual case safety reports, safety data exchange procedures inter- and intra-companies. Signal Detection: Data Mining and Signal Management (GVP IX), use of adverse experience and prescription data to determine signals. Statistical methods for signal detection.

  • Pharmacoepidemiology

  • Pharmacovigilance Regulations and Guidelines

    European Union Directives on Pharmacovigilance, The Rules Governing Medicinal Products in the European Union Volume 9/9A Pharmacovigilance Medicinal Products for Human and Veterinary Use; Committee for Human Medicinal Products ; Guidelines for Post Authorisation Safety Studies; The Medicines for Human Use (Clinical Trials) Regulations 2004; ABPI Code of Practice (relevant parts). Summary of Product Characteristics; Periodic Safety Update Reports; Drugs, Biologicals and Devices. USA: Food and Drug Administration Regulations, including expedited and periodic reporting; investigational new drugs (IND), new drug applications (NDA); biologics, vaccines and medical devices. CIOMS initiatives (I,II,III,IV, V, VI and VII). ICH guidelines Other countries, e.g. Japan, as appropriate. Communication between authorities.

  • Pharmacovigilance Regulations and Guidelines

    Europe: Clinical trial regulation, licence applications. MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. Biologics, vaccines and medical devices. Summary of product characteristics. FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). Other countries PV regulations and guidelines as appropriate. Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Pharmacovigilance System Master File (PSMF) (GVP II). Pharmacovigilance inspections (GVP III) and audits (GVP IV).

  • Principles of Pharmacovigilance

    Historical perspective of pharmacovigilance. Council for International Organisations of Medical Sciences (CIOMS) International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Drug safety terminology and definitions of specific adverse events. Reference sources Hypothesis generation and testing. Animal toxicology and its relevance to man. Mechanisms of adverse drug reactions(ADRs). Introduction to epidemiology of ADRs. Causality assessment and evaluation of case reports Principles of safety evaluation during a drug's life-cycle. The Risk/Benefit profile of a drug and perception of risk Introduction to risk management systems Labelling (SmPCs and PILs) Overview of the role of the Qualified Person Drugs withdrawn for safety reasons. Descriptive statistics (populations, mean , median, mode, measures of variation, confidence limits) Seminar Presentation

  • Spontaneous Reporting and Adverse Drug Reactions in Special Groups

    Sources and optimum composition of spontaneous reports; advantages and limitations of spontaneous report data; factors affecting spontaneous reporting of ADRs; how the MHRA handles spontaneous data, including: data collection (The Yellow Card System), signal detection and analysis, interaction with the Industry, demonstrations of the ADROIT system; how some other agencies collect data: EMEA, Eudravigilance, the MEDWATCH Program in the US, French Regional Pharmacovigilance Centres; company procedures for handling data, to include: methods used for collection and follow-up, company databases, report on the data, reports with non prescription medicines; putting reports in perspective; exposure data (sales vs scripts patients exposed), disease registries, ONS etc; examples of signals identified through spontaneous reports; the potential impact of spontaneous reports for patients, prescribers and manufacturers through knowledge of previous case histories; Drug interactions - pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples; stages in foetal development and sensitivity to teratogens; drug administration in pregnancy - teratogenicity and other toxic effects on foetal tissue; Teratology Information Service, epidemiology of congenital malformations; use of drugs in nursing mothers - effects on lactation; infant toxicity relevance of animal toxicology data; other special groups, including the elderly and those with hepatic and renal impairment; drug overdoses - Poisons Information Centres.

Year 2

Core Modules

Optional

  • Adverse Drug Reactions by Major Body Systems

    Basic statistical significance tests, Classification of ADRs, Pharmacokinetics (ADME), pharmaceutical, pharmacokinetic, pharmacodynamic and pharmacogenetic factors leading to ADRs, Physiological control systems. The adverse effect of drugs on the immune, respiratory, cardiovascular, central nervous, haematological, renal and hepatic systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Criteria for defining ADRs. Exercises to evaluate cases and how these can be determined.

  • Adverse Drug Reactions by Major Body Systems I

  • Adverse Drug Reactions by Major Body Systems II

    The adverse effect of drugs on the renal, cutaneous, gastrointestinal, musculoskeletal, and endocrine systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Drug interactions: pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples. Drug administration in pregnancy: stages in foetal development and sensitivity to teratogens and other toxic effects on foetal tissue. Use of drugs in nursing mothers: effects on lactation, infant toxicity, relevance of animal toxicology data. Other special groups including: drug use in paediatric patients, the elderly and those with hepatic and renal impairment. Drug overdoses - Poisons Information Centres. Lack of efficacy and Off-label use (GVP VI). Reference to Periodic Safety Update Reports (GVP VII) and Post-authorisation safety studies (GVP VIII).

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials; phases of clinical trials, trial design and analysis; adverse event reporting and monitoring in clinical trials; protocol development and case record form design; GCP; exercise on protocol design and safety monitoring aspects of a study; safety issues in clinical pharmacology studies; ethics committees; randomisation and the breaking of study codes; investigator brochures; presentation of safety data from clinical trials - study reports, (EU Clinical Trials Directive, Quarterly and Annual Safety Reports,FDA Investigational New Drug Safety reports and Annual Reports), MAAs; NDAs, SPC; large scale endpoint studies and Safety Monitoring Boards; statistical considerations; exercise on interpretation and presentation of safety data; laboratory data: meaning, analysis and presentation; role of Clinical Research Organisations and safety; limitations of clinical trials in determining the safety profile of a new medicine.

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials. Phases of clinical trials: trial design and analysis (including adaptive design), adverse event reporting and monitoring in clinical trials, protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP), protocol design and safety monitoring aspects of a study, safety biomarkers, safety issues in clinical pharmacology studies, ethics committees; randomisation and the breaking of study codes. Investigator brochures; presentation of safety data from clinical trials; study reports; product licence applications format and organisation of the CTD clinical summaries (ini particular the SCS) as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials in determining the safety profile of a new medicine. Statistics. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products (including concepts of IMP, non-IMP). Investigator notifications (IND). Management of urgent safety measures.

  • Labelling and Risk Management

  • Management of Pharmacovigilance Data

    Information Systems and Compliance Use of SOPs, working practices & guidelines in data management. Auditing, quality assurance & inspections. Pharmacovigilance Databases Database design (vendor & bespoke systems), customisation, implementation and validation (relevant regulations including data privacy). Maintenance of company systems & upgrades. Coding (medical terminology, products and lists of values) Medical terminology including updates. Products and coding).Pharmacovigilance data values. Electronic Reporting and Safety Data Exchange Interaction with agencies, seeking information and for electronic interchange. Global electronic reporting of individual case safety reports. Safety data exchange procedures inter- and intra-companies. Risk Management Safety data in decision making; management of identified and potential risks. Practical risk management including effective communication. Signal Detection and Data Mining Use of adverse experience and prescription data to determine signals. Statistical methods for signal detection; data mining.

  • Management of Pharmacovigilance Data

    Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data (methods used for collection and follow-up). Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, auditing, quality assurance and inspections. PV Databases: Database design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Coding (medical terminology, products and lists of values), PV data values. Electronic Reporting and Safety Data Exchange: Interaction with agencies for seeking information and for electronic interchange, global electronic reporting of individual case safety reports, safety data exchange procedures inter- and intra-companies. Signal Detection: Data Mining and Signal Management (GVP IX), use of adverse experience and prescription data to determine signals. Statistical methods for signal detection.

  • Pharmacoepidemiology

  • Pharmacovigilance Regulations and Guidelines

    European Union Directives on Pharmacovigilance, The Rules Governing Medicinal Products in the European Union Volume 9/9A Pharmacovigilance Medicinal Products for Human and Veterinary Use; Committee for Human Medicinal Products ; Guidelines for Post Authorisation Safety Studies; The Medicines for Human Use (Clinical Trials) Regulations 2004; ABPI Code of Practice (relevant parts). Summary of Product Characteristics; Periodic Safety Update Reports; Drugs, Biologicals and Devices. USA: Food and Drug Administration Regulations, including expedited and periodic reporting; investigational new drugs (IND), new drug applications (NDA); biologics, vaccines and medical devices. CIOMS initiatives (I,II,III,IV, V, VI and VII). ICH guidelines Other countries, e.g. Japan, as appropriate. Communication between authorities.

  • Pharmacovigilance Regulations and Guidelines

    Europe: Clinical trial regulation, licence applications. MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. Biologics, vaccines and medical devices. Summary of product characteristics. FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). Other countries PV regulations and guidelines as appropriate. Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Pharmacovigilance System Master File (PSMF) (GVP II). Pharmacovigilance inspections (GVP III) and audits (GVP IV).

  • Principles of Pharmacovigilance

    Historical perspective of pharmacovigilance. Council for International Organisations of Medical Sciences (CIOMS) International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Drug safety terminology and definitions of specific adverse events. Reference sources Hypothesis generation and testing. Animal toxicology and its relevance to man. Mechanisms of adverse drug reactions(ADRs). Introduction to epidemiology of ADRs. Causality assessment and evaluation of case reports Principles of safety evaluation during a drug's life-cycle. The Risk/Benefit profile of a drug and perception of risk Introduction to risk management systems Labelling (SmPCs and PILs) Overview of the role of the Qualified Person Drugs withdrawn for safety reasons. Descriptive statistics (populations, mean , median, mode, measures of variation, confidence limits) Seminar Presentation

  • Project - Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; development of company procedures; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Project, Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; risk management; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Spontaneous Reporting and Adverse Drug Reactions in Special Groups

    Sources and optimum composition of spontaneous reports; advantages and limitations of spontaneous report data; factors affecting spontaneous reporting of ADRs; how the MHRA handles spontaneous data, including: data collection (The Yellow Card System), signal detection and analysis, interaction with the Industry, demonstrations of the ADROIT system; how some other agencies collect data: EMEA, Eudravigilance, the MEDWATCH Program in the US, French Regional Pharmacovigilance Centres; company procedures for handling data, to include: methods used for collection and follow-up, company databases, report on the data, reports with non prescription medicines; putting reports in perspective; exposure data (sales vs scripts patients exposed), disease registries, ONS etc; examples of signals identified through spontaneous reports; the potential impact of spontaneous reports for patients, prescribers and manufacturers through knowledge of previous case histories; Drug interactions - pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples; stages in foetal development and sensitivity to teratogens; drug administration in pregnancy - teratogenicity and other toxic effects on foetal tissue; Teratology Information Service, epidemiology of congenital malformations; use of drugs in nursing mothers - effects on lactation; infant toxicity relevance of animal toxicology data; other special groups, including the elderly and those with hepatic and renal impairment; drug overdoses - Poisons Information Centres.

Year 3

Core Modules

Optional

  • Adverse Drug Reactions by Major Body Systems II

    The adverse effect of drugs on the renal, cutaneous, gastrointestinal, musculoskeletal, and endocrine systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Drug interactions: pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples. Drug administration in pregnancy: stages in foetal development and sensitivity to teratogens and other toxic effects on foetal tissue. Use of drugs in nursing mothers: effects on lactation, infant toxicity, relevance of animal toxicology data. Other special groups including: drug use in paediatric patients, the elderly and those with hepatic and renal impairment. Drug overdoses - Poisons Information Centres. Lack of efficacy and Off-label use (GVP VI). Reference to Periodic Safety Update Reports (GVP VII) and Post-authorisation safety studies (GVP VIII).

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials; phases of clinical trials, trial design and analysis; adverse event reporting and monitoring in clinical trials; protocol development and case record form design; GCP; exercise on protocol design and safety monitoring aspects of a study; safety issues in clinical pharmacology studies; ethics committees; randomisation and the breaking of study codes; investigator brochures; presentation of safety data from clinical trials - study reports, (EU Clinical Trials Directive, Quarterly and Annual Safety Reports,FDA Investigational New Drug Safety reports and Annual Reports), MAAs; NDAs, SPC; large scale endpoint studies and Safety Monitoring Boards; statistical considerations; exercise on interpretation and presentation of safety data; laboratory data: meaning, analysis and presentation; role of Clinical Research Organisations and safety; limitations of clinical trials in determining the safety profile of a new medicine.

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials. Phases of clinical trials: trial design and analysis (including adaptive design), adverse event reporting and monitoring in clinical trials, protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP), protocol design and safety monitoring aspects of a study, safety biomarkers, safety issues in clinical pharmacology studies, ethics committees; randomisation and the breaking of study codes. Investigator brochures; presentation of safety data from clinical trials; study reports; product licence applications format and organisation of the CTD clinical summaries (ini particular the SCS) as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials in determining the safety profile of a new medicine. Statistics. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products (including concepts of IMP, non-IMP). Investigator notifications (IND). Management of urgent safety measures.

  • Management of Pharmacovigilance Data

    Information Systems and Compliance Use of SOPs, working practices & guidelines in data management. Auditing, quality assurance & inspections. Pharmacovigilance Databases Database design (vendor & bespoke systems), customisation, implementation and validation (relevant regulations including data privacy). Maintenance of company systems & upgrades. Coding (medical terminology, products and lists of values) Medical terminology including updates. Products and coding).Pharmacovigilance data values. Electronic Reporting and Safety Data Exchange Interaction with agencies, seeking information and for electronic interchange. Global electronic reporting of individual case safety reports. Safety data exchange procedures inter- and intra-companies. Risk Management Safety data in decision making; management of identified and potential risks. Practical risk management including effective communication. Signal Detection and Data Mining Use of adverse experience and prescription data to determine signals. Statistical methods for signal detection; data mining.

  • Management of Pharmacovigilance Data

    Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data (methods used for collection and follow-up). Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, auditing, quality assurance and inspections. PV Databases: Database design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Coding (medical terminology, products and lists of values), PV data values. Electronic Reporting and Safety Data Exchange: Interaction with agencies for seeking information and for electronic interchange, global electronic reporting of individual case safety reports, safety data exchange procedures inter- and intra-companies. Signal Detection: Data Mining and Signal Management (GVP IX), use of adverse experience and prescription data to determine signals. Statistical methods for signal detection.

  • Pharmacovigilance Regulations and Guidelines

    European Union Directives on Pharmacovigilance, The Rules Governing Medicinal Products in the European Union Volume 9/9A Pharmacovigilance Medicinal Products for Human and Veterinary Use; Committee for Human Medicinal Products ; Guidelines for Post Authorisation Safety Studies; The Medicines for Human Use (Clinical Trials) Regulations 2004; ABPI Code of Practice (relevant parts). Summary of Product Characteristics; Periodic Safety Update Reports; Drugs, Biologicals and Devices. USA: Food and Drug Administration Regulations, including expedited and periodic reporting; investigational new drugs (IND), new drug applications (NDA); biologics, vaccines and medical devices. CIOMS initiatives (I,II,III,IV, V, VI and VII). ICH guidelines Other countries, e.g. Japan, as appropriate. Communication between authorities.

  • Pharmacovigilance Regulations and Guidelines

    Europe: Clinical trial regulation, licence applications. MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. Biologics, vaccines and medical devices. Summary of product characteristics. FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). Other countries PV regulations and guidelines as appropriate. Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Pharmacovigilance System Master File (PSMF) (GVP II). Pharmacovigilance inspections (GVP III) and audits (GVP IV).

  • Principles of Pharmacovigilance

    Historical perspective of pharmacovigilance. Council for International Organisations of Medical Sciences (CIOMS) International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Drug safety terminology and definitions of specific adverse events. Reference sources Hypothesis generation and testing. Animal toxicology and its relevance to man. Mechanisms of adverse drug reactions(ADRs). Introduction to epidemiology of ADRs. Causality assessment and evaluation of case reports Principles of safety evaluation during a drug's life-cycle. The Risk/Benefit profile of a drug and perception of risk Introduction to risk management systems Labelling (SmPCs and PILs) Overview of the role of the Qualified Person Drugs withdrawn for safety reasons. Descriptive statistics (populations, mean , median, mode, measures of variation, confidence limits) Seminar Presentation

  • Project - Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; development of company procedures; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Project, Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; risk management; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Spontaneous Reporting and Adverse Drug Reactions in Special Groups

    Sources and optimum composition of spontaneous reports; advantages and limitations of spontaneous report data; factors affecting spontaneous reporting of ADRs; how the MHRA handles spontaneous data, including: data collection (The Yellow Card System), signal detection and analysis, interaction with the Industry, demonstrations of the ADROIT system; how some other agencies collect data: EMEA, Eudravigilance, the MEDWATCH Program in the US, French Regional Pharmacovigilance Centres; company procedures for handling data, to include: methods used for collection and follow-up, company databases, report on the data, reports with non prescription medicines; putting reports in perspective; exposure data (sales vs scripts patients exposed), disease registries, ONS etc; examples of signals identified through spontaneous reports; the potential impact of spontaneous reports for patients, prescribers and manufacturers through knowledge of previous case histories; Drug interactions - pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples; stages in foetal development and sensitivity to teratogens; drug administration in pregnancy - teratogenicity and other toxic effects on foetal tissue; Teratology Information Service, epidemiology of congenital malformations; use of drugs in nursing mothers - effects on lactation; infant toxicity relevance of animal toxicology data; other special groups, including the elderly and those with hepatic and renal impairment; drug overdoses - Poisons Information Centres.

Year 4

Core Modules

Optional

  • Adverse Drug Reactions by Major Body Systems II

    The adverse effect of drugs on the renal, cutaneous, gastrointestinal, musculoskeletal, and endocrine systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Drug interactions: pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples. Drug administration in pregnancy: stages in foetal development and sensitivity to teratogens and other toxic effects on foetal tissue. Use of drugs in nursing mothers: effects on lactation, infant toxicity, relevance of animal toxicology data. Other special groups including: drug use in paediatric patients, the elderly and those with hepatic and renal impairment. Drug overdoses - Poisons Information Centres. Lack of efficacy and Off-label use (GVP VI). Reference to Periodic Safety Update Reports (GVP VII) and Post-authorisation safety studies (GVP VIII).

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials; phases of clinical trials, trial design and analysis; adverse event reporting and monitoring in clinical trials; protocol development and case record form design; GCP; exercise on protocol design and safety monitoring aspects of a study; safety issues in clinical pharmacology studies; ethics committees; randomisation and the breaking of study codes; investigator brochures; presentation of safety data from clinical trials - study reports, (EU Clinical Trials Directive, Quarterly and Annual Safety Reports,FDA Investigational New Drug Safety reports and Annual Reports), MAAs; NDAs, SPC; large scale endpoint studies and Safety Monitoring Boards; statistical considerations; exercise on interpretation and presentation of safety data; laboratory data: meaning, analysis and presentation; role of Clinical Research Organisations and safety; limitations of clinical trials in determining the safety profile of a new medicine.

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials. Phases of clinical trials: trial design and analysis (including adaptive design), adverse event reporting and monitoring in clinical trials, protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP), protocol design and safety monitoring aspects of a study, safety biomarkers, safety issues in clinical pharmacology studies, ethics committees; randomisation and the breaking of study codes. Investigator brochures; presentation of safety data from clinical trials; study reports; product licence applications format and organisation of the CTD clinical summaries (ini particular the SCS) as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials in determining the safety profile of a new medicine. Statistics. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products (including concepts of IMP, non-IMP). Investigator notifications (IND). Management of urgent safety measures.

  • Management of Pharmacovigilance Data

    Information Systems and Compliance Use of SOPs, working practices & guidelines in data management. Auditing, quality assurance & inspections. Pharmacovigilance Databases Database design (vendor & bespoke systems), customisation, implementation and validation (relevant regulations including data privacy). Maintenance of company systems & upgrades. Coding (medical terminology, products and lists of values) Medical terminology including updates. Products and coding).Pharmacovigilance data values. Electronic Reporting and Safety Data Exchange Interaction with agencies, seeking information and for electronic interchange. Global electronic reporting of individual case safety reports. Safety data exchange procedures inter- and intra-companies. Risk Management Safety data in decision making; management of identified and potential risks. Practical risk management including effective communication. Signal Detection and Data Mining Use of adverse experience and prescription data to determine signals. Statistical methods for signal detection; data mining.

  • Management of Pharmacovigilance Data

    Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data (methods used for collection and follow-up). Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, auditing, quality assurance and inspections. PV Databases: Database design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Coding (medical terminology, products and lists of values), PV data values. Electronic Reporting and Safety Data Exchange: Interaction with agencies for seeking information and for electronic interchange, global electronic reporting of individual case safety reports, safety data exchange procedures inter- and intra-companies. Signal Detection: Data Mining and Signal Management (GVP IX), use of adverse experience and prescription data to determine signals. Statistical methods for signal detection.

  • Pharmacovigilance Regulations and Guidelines

    European Union Directives on Pharmacovigilance, The Rules Governing Medicinal Products in the European Union Volume 9/9A Pharmacovigilance Medicinal Products for Human and Veterinary Use; Committee for Human Medicinal Products ; Guidelines for Post Authorisation Safety Studies; The Medicines for Human Use (Clinical Trials) Regulations 2004; ABPI Code of Practice (relevant parts). Summary of Product Characteristics; Periodic Safety Update Reports; Drugs, Biologicals and Devices. USA: Food and Drug Administration Regulations, including expedited and periodic reporting; investigational new drugs (IND), new drug applications (NDA); biologics, vaccines and medical devices. CIOMS initiatives (I,II,III,IV, V, VI and VII). ICH guidelines Other countries, e.g. Japan, as appropriate. Communication between authorities.

  • Pharmacovigilance Regulations and Guidelines

    Europe: Clinical trial regulation, licence applications. MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. Biologics, vaccines and medical devices. Summary of product characteristics. FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). Other countries PV regulations and guidelines as appropriate. Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Pharmacovigilance System Master File (PSMF) (GVP II). Pharmacovigilance inspections (GVP III) and audits (GVP IV).

  • Project - Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; development of company procedures; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Project, Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; risk management; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Spontaneous Reporting and Adverse Drug Reactions in Special Groups

    Sources and optimum composition of spontaneous reports; advantages and limitations of spontaneous report data; factors affecting spontaneous reporting of ADRs; how the MHRA handles spontaneous data, including: data collection (The Yellow Card System), signal detection and analysis, interaction with the Industry, demonstrations of the ADROIT system; how some other agencies collect data: EMEA, Eudravigilance, the MEDWATCH Program in the US, French Regional Pharmacovigilance Centres; company procedures for handling data, to include: methods used for collection and follow-up, company databases, report on the data, reports with non prescription medicines; putting reports in perspective; exposure data (sales vs scripts patients exposed), disease registries, ONS etc; examples of signals identified through spontaneous reports; the potential impact of spontaneous reports for patients, prescribers and manufacturers through knowledge of previous case histories; Drug interactions - pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples; stages in foetal development and sensitivity to teratogens; drug administration in pregnancy - teratogenicity and other toxic effects on foetal tissue; Teratology Information Service, epidemiology of congenital malformations; use of drugs in nursing mothers - effects on lactation; infant toxicity relevance of animal toxicology data; other special groups, including the elderly and those with hepatic and renal impairment; drug overdoses - Poisons Information Centres.

Year 5

Core Modules

Optional

  • Adverse Drug Reactions by Major Body Systems II

    The adverse effect of drugs on the renal, cutaneous, gastrointestinal, musculoskeletal, and endocrine systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Drug interactions: pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples. Drug administration in pregnancy: stages in foetal development and sensitivity to teratogens and other toxic effects on foetal tissue. Use of drugs in nursing mothers: effects on lactation, infant toxicity, relevance of animal toxicology data. Other special groups including: drug use in paediatric patients, the elderly and those with hepatic and renal impairment. Drug overdoses - Poisons Information Centres. Lack of efficacy and Off-label use (GVP VI). Reference to Periodic Safety Update Reports (GVP VII) and Post-authorisation safety studies (GVP VIII).

  • Drug Safety in Clinical Trials

    Animal toxicology findings and their relevance to clinical trials. Phases of clinical trials: trial design and analysis (including adaptive design), adverse event reporting and monitoring in clinical trials, protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP), protocol design and safety monitoring aspects of a study, safety biomarkers, safety issues in clinical pharmacology studies, ethics committees; randomisation and the breaking of study codes. Investigator brochures; presentation of safety data from clinical trials; study reports; product licence applications format and organisation of the CTD clinical summaries (ini particular the SCS) as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials in determining the safety profile of a new medicine. Statistics. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products (including concepts of IMP, non-IMP). Investigator notifications (IND). Management of urgent safety measures.

  • Management of Pharmacovigilance Data

    Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data (methods used for collection and follow-up). Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, auditing, quality assurance and inspections. PV Databases: Database design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Coding (medical terminology, products and lists of values), PV data values. Electronic Reporting and Safety Data Exchange: Interaction with agencies for seeking information and for electronic interchange, global electronic reporting of individual case safety reports, safety data exchange procedures inter- and intra-companies. Signal Detection: Data Mining and Signal Management (GVP IX), use of adverse experience and prescription data to determine signals. Statistical methods for signal detection.

  • Pharmacovigilance Regulations and Guidelines

    Europe: Clinical trial regulation, licence applications. MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. Biologics, vaccines and medical devices. Summary of product characteristics. FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). Other countries PV regulations and guidelines as appropriate. Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Pharmacovigilance System Master File (PSMF) (GVP II). Pharmacovigilance inspections (GVP III) and audits (GVP IV).

  • Project - Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; development of company procedures; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

  • Project, Pharmacovigilance

    Project topics will be of a varied nature within the scope of the programme and will cover the breadth of the discipline and student interest (e.g. research into adverse drug reactions; interpretation of regulations and guidelines; clinical trials; risk management; safety evaluations; legal reports; systematic reviews). Academic staff may submit project titles and brief synopses for student choices but students may suggest their own projects which may be done at their place of work. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning., Each project will be supervised by at least one member of staff and assessment will involve at least one other.

Fees & funding

Fees 2014

Dissertation module is charged at £1970

Discounts are available for International students if payment is made in full at registration

View detailed information about tuition fees

Other financial support

Find out more about other financial support available to UK and EU students

Living costs / accommodation

The University of Hertfordshire offers a great choice of student accommodation, on campus or nearby in the local area, to suit every student budget.

View detailed information about our accommodation

How to apply

2014

Start DateEnd DateLink
19/01/201515/01/2016Apply online (Part Time)
21/01/201531/01/2016Apply online (Part Time)

2015

Start DateEnd DateLink
28/09/201520/05/2016Apply online (Part Time)
21/01/201631/01/2017Apply online (Part Time)
24/09/201531/07/2016Apply online (Part Time)