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Seminar 6: Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety

Course Description


Pharmacovigilance, i.e. the standard of constant monitoring of the safety of medicinal products after authorisation, is an important obligation of the marketing authorisation holder (MAH) and authorities. It requires constant exchange between companies and authorities. The EU legislation requires MAHs to provide the competent authorities with a description of their pharmacovigilance and risk management systems. Collecting, monitoring, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicinal products is conducted to identify new information about hazards associated with medicinal products and preventing harm to patients. Periodic Safety Update Reports (PSURs) and Risk Management Plans need to be communicated regularly. Depending on the signals observed, the resulting actions can include changes to the Safety Part of the SmPC or even measures on the marketing authorisation such as suspension or limitation of authorised therapeutic indications.


- Pharmacovigilance concepts and specific aspects relevant to biologicals
- Legal requirements and safety deliverables
- Regulatory expectations
- Risk management approach
- Operational aspects:PhV system, business processes, project managment, quality oversight, saftey governance models, audits and inspections


- Provides the basis of the regulatory environment and processes to be followed related to pharmacovigilance
- Understand the requirements and principles of pharmacovigilance of medicinal products and the method of pharmacoepidemiological studies
- Understand and support the pre- and post-approval obligations to keep marketing authorisations valid
- Provides the knowledge on the appropriate preparation of a Periodic Safety Update Report (PSUR) and Risk Management Plan (RMP)
- Learn to handle regulatory measures and processes such as an urgent safety restriction, a dear doctor letter, changes to the Safety Part of the SmPC, measures on the marketing authorization


Day 1, Wednesday, 03 June 2015

12.00 - 13.00 Lunch

13.00 - 14.00 Introduction to the pharmacovigilance (Monika Pietrek, Pietrek Associates GmbH)

Are authorised products safe?
What do patients/consumers and physicians expect?
Biologicals: from vaccines to immunotherapy
Benefit/risk concept at the individual and the population level
Principles of surveillance
The legal framework conceptually: national legislation, EU legislation, CIOMS, ICH

14.00 - 15.00 Case Study (Monika Pietrek, Pietrek Associates GmbH)

15.00 - 15.30 Coffee break

15.30 - 16.00 Pharmacovigilance System and core PV processes I (Monika Pietrek, Pietrek Associates GmbH)


16.00 - 16.15 Questions and Answers

16.15 - 17.15 EU Regulatory requirements at time of authorisation (Christine Bendall, Pharview Ltd.)

How is the safety information presented in the relevant sections of the CTD submitted with the MAA
The PhV system and the role of the EU QPPV
Agreement on the labeling text, the SmPC
Post-authorisation commitments
Risk Management Plans

17.15 - 17.45 Case Study (Monika Pietrek, Pietrek Associates GmbH)

17.45 - 18.00 Wrap-up

Day 2, Thursday, 04 June 2015

09.15 - 09.30 Rehearsal Key Messages Day 1 (Christine Bendall, Pharview Ltd., Monika Pietrek, Pietrek Associates GmbH)

09.30 - 10.15 EU Regulatory requirements post-authorisation (Christine Bendall, Pharview Ltd.)

Expedited reporting of safety information
Periodic Safety Reports (DSURs/PSURs/PBRERs)
Company Core Safety Information
Type II variations related to safety aspects
Urgent safety restrictions
Interaction of the company with agencies on safety aspects
Communication with the public

10.15 - 10.30 Coffee break

10.30 - 11.30 Pharmacovigilance concepts and core processes II (Monika Pietrek, Pietrek Associates GmbH)

Brief introduction into epidemiology
Methods of studying benefits and risks
Weighting evidence
Signal detection and investigation

11.30 - 12.15 Case Study (Christine Bendall, Pharview Ltd.)

12.15 - 13.15 Lunch

13.15 - 14.15 Pharmacovigilance concepts and core processes III (Glyn Belcher, PV Consultancy UG)

14.15 - 15.00 Case Study (Glyn Belcher, PV Consultancy UG)

15.00 - 15.30 Coffee break

15.30 - 16.00 Differences between EU and non-EU requirements with respect to PSMF, ICSR, periodic reports, RMP, product information (Christine Bendall, Pharview Ltd.)

16.00 - 17.00 Case Study (Monika Pietrek, Pietrek Associates GmbH)

17.00 - 18.00 Implications of the EU PV legislation - Questions & Answers (Christine Bendall, Pharview Ltd., Glyn Belcher, PV Consultancy UG, Monika Pietrek, Pietrek Associates GmbH)

Day 3, Friday, 05 June 2015

09.15 - 09.45 Rehearsal Key Messages Day 1 and 2 (Glyn Belcher, PV Consultancy UG, Monika Pietrek, Pietrek Associates GmbH)

09.45 - 10.30 Benefit Risk Management in Practice (Glyn Belcher, PV Consultancy UG)

Benefit - Risk frame work
Risk management planning
Risk mitigation
Effectiveness of risk minimisation
Progress reports

10.30 - 11.00 Coffee break

11.00 - 11.45 Case Study (Students) (Glyn Belcher, PV Consultancy UG)

11.45 - 12.00 Case Study (Plenary) (Glyn Belcher, PV Consultancy UG)

12.00 - 13.00 Lunch

13.00 - 13.45 Safety Communication and Transparency (Monika Pietrek, Pietrek Associates GmbH)

Risk communication to HCPs, patients/consumers and public at large
Erice Declaration
PRAC minutes
RMP summaries

13.45 - 14.45 Case Study (Monika Pietrek, Pietrek Associates GmbH)

14.45 - 15.15 Coffee break

15.15 - 16.00 PV Quality Management

PV system performance
Quality control
Audits and inspections
CAPA management
Quality oversight

16.00 -17.00 Case Study (Monika Pietrek, Pietrek Associates GmbH)

17.00 - 17.30 Questions & Answers

17.30 End of Seminar 6

Entry Requirements

English language knowledge

Course Fees

1.400 EUR for companies, 920 EUR for academics/government (+19% German VAT)

Email Enquiry

Recipient: European Centre of Regulatory Affairs, EUCRAF
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