| Module |
Credits |
Compulsory/optional |
|
Pharmacovigilance Regulations and Guidelines
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below. Emphasis is placed on the interpretation and impact of pharmacovigilance regulations on the pharmaceutical industry both pre- and post-authorisation.
EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. EU Medical Device Regulation. Clinical trial regulation and license applications. The MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). New Post Marketing Safety Reporting (PMSR) requirements for combination products (81 FR 92603). Other countries PV regulations and guidelines as appropriate (e.g. Japanese, China) and emerging regional models (e.g. Africa). Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Difference in requirements for small molecules, biologics, vaccines and medical devices. Summary of product characteristics.
PV System Master File (PSMF) (GVP II). PV inspections (GVP III) and audits (GVP IV). GDPR and its relevance to PV. AI & machine learning in PV; expectations, validation, assessment in PV inspections and potential signal management use. Guidance from FDA CDRH division in 2019 and emerging guidance from MHRA.
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day block teaching. |
|
Drug Safety in Clinical Trials
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below.
Animal toxicology findings and relevance to clinical trials, phases of clinical trials, adverse event reporting and safety monitoring in clinical trials. Protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP) and Ethic committees. Randomisation and the breaking of study codes, Investigator brochures; presentation of safety data from clinical trials and study reports. Revised CTFG guidelines and the RSI. Product license applications format and organisation of the CTD clinical summaries as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 (CT-3) including concepts of IMP, non-IMP. Investigator notifications (IND) and the management of urgent safety measures. Combination products; handling IMP's with a device constituent and use of technologies to support safety activities in clinical trials e.g., wearables. Clinical trials in rare diseases and oncology; available evidence and safety surveillance.
Post authorisation efficacy and safety studies (PAES, PASS) (GVP VIII) and statistics will also be covered.
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
|
Adverse Drug Reactions by Major Body Systems II
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below.
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. Varying the surveillance approach to identifying events via symptoms. 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).
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
|
Management and Reporting of Pharmacovigilance Data
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below.
Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data.
Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, data auditing, quality assurance, inspections and considerations for introducing process automation.
PV data sources; relative value and their management (e.g. spontaneous, literature, interventional clinical trials, NIS, patient support programs, market access programs, social media, digital channels. Drivers for re-opening in ICH E2D in the digital era.
PV Databases design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Potential to apply emerging automation technologies (e.g. AI, machine learning, natural language processing) to augment the management, analysis and reporting of PV data. Coding, PV data values. Electronic Reporting and Safety Data Exchange. Signal Detection: Data Mining and Signal Management (GVP IX), good practices for signal management (e.g. IMI-PROTECT guidances) and emerging predictive safety modelling approaches in clinical trials. Utilisation of EVDAS, Vigibase & FAERs; GVP IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspect adverse drug reaction.
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
|
Project, Pharmacovigilance
|
60 Credits |
Optional |
| The Project provides the opportunity for extended, in-depth study on a selected aspect from within the scope of the programme and will cover the breadth of the discipline and student interest. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning.
Projects are non-laboratory based and are usually conducted at the student's place of work. All students have a University supervisor allocated to them, in addition to a workplace supervisor. Both supervisors will guide the student in their choice of project work, literature search, research methods, data evaluation and report writing.
Tutorials with supervisors will include discussion on aims, objectives current theories, research design, data collection and analysis, and the structure of the report. |
|
Principles of Pharmacovigilance
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below.
Historical perspective of pharmacovigilance, international co-operation in pharmacovigilance, drug safety terminology and definitions. Pharmacovigilance systems and their quality management systems (GVP I). Principles of safety evaluation during a drug's lifecycle, risk perception and benefit risk assessment (high-level). Examples of drugs withdrawn for safety reasons. Differences between medicinal products e.g., small molecules, biological, combination products and medical devices. Causality assessment, reference sources of safety information.
Sources and optimum composition of spontaneous reports (elements of GVP VI), advantages and limitations of spontaneous report data. Factors affecting spontaneous reporting of ADRs. How the MHRA handles spontaneous data (the Yellow Card System, data collection, signal detection and analysis). MEDWATCH Program in the US, and other regional pharmacovigilance centres. Licence partners and safety data exchange agreements (elements of GVP VI). Additional monitoring overview (GVP X).
Descriptive statistics used in drug safety surveillance. Overview of general types of technologies/systems/applications in use to enable pharmacovigilance activities.
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
|
Adverse Drug Reactions by Major Body Systems I
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below:
The classification of ADRs, pharmaceutical, pharmacokinetic, pharmacodynamic and pharmacogenetic factors leading to ADRs, clinical chemistry (reference ranges). Body systems/organ classes. The adverse effect of drugs on the hepatobiliary, immune, respiratory, cardiovascular, central nervous, haematological; clinical presentations, case histories and practical examples of adverse drug reactions. Investigations including monitoring of vital signs, important laboratory and diagnostic tests.
Clinical presentations, case histories and practical examples of adverse drug reactions. Class effects e.g., PD1 class effects. Criteria for defining ADRs. Exercises to evaluate cases and how these can be determined. Examples of causality models / criteria, such as Edwards, and their application.
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
|
Pharmacoepidemiology
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below:
The development of pharmacoepidemiology as a scientific entity; hypothesis generation and testing, epidemiology of disease, epidemiological study designs, case reports, case series, case control and cohort studies.
Post-authorisation surveillance; history and critical analysis and epidemiological implications,
non-interventional -v- interventional studies; selection and design examples and critical evaluation. Data selection; quality -v- quantity. A comparative global review of record-linkage databases (strengths and weaknesses) study design considerations. Other sources: Registries and the Cochrane Collaborative database. Performing meta-analysis and handling large data-sets considerations.
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
|
Risk Management and Labelling
|
15 Credits |
Optional |
| Students will study a range of content including the topics detailed below:
Principles of Risk Management and how risks are classified in the EU. Review of global requirement for risk management and managing these requirements. On-going benefit risk assessment, expert views, pre- and post-authorisation data. Practical risk management (GVP V), including effective communication; management of identified and potential risks. Pharmacovigilance Activities (routine & additional). Risk minimisation measures (routine & additional), selection of tools and indicators (GVP XVI). Safety communication (GVP XV) including communication of risk and public participation in PV (GVP XI). Communication of risk via digital channels/technologies. Supporting stakeholders in putting risk into context, crisis management (e.g. product withdrawal, USR, etc).
Guidelines/directives on labelling: CIOMS III, IV and V initiatives, ICH guidelines, Good labelling practice. Pharmacoepidemiology and labelling, Development Core Safety information, Patient Information Leaflets, Data Sheets, Summary of Product Characteristics and Variations (Type I and Type II). Implications of MedDRA & applying frequency in labels. Handling region/country variations. Labelling technology and how label is used for assessment (Case, signal etc).
The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course. |
