In the EU, all companies are required to provide risk management plans (RMPs) for every new product, whether generic products or new chemical entities, and these RMPs must also be modified and updated throughout the lifetime of a medicine. This intensive one-day course will provide you with an invaluable overview of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. You will discuss best practice for using the EU templates and risk minimisation tools to enhance the benefit/risk of your product.
The programme has been fully revised to cover the latest updates and new requirements, including amendments made to the previous template.
Benefits of attending:
- Gain an overview of ICH and EU RMPs - their production and ongoing maintenance
- Clarify the documentation to be supplied to regulators and the process for RMPs
- Learn what happened in the EU RMP update and explore the new requirements
- Discuss the EU templates and their completion - generic and innovative products
- Understand the relationship between RMPs, post-authorisation safety and efficacy studies, safety reviews and PBRERs
- Discuss the RMP and risk minimisation follow-up
Certification:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
Introduction, welcome and objectives
An introduction to RMPs
- Outline and purpose of ICH E2E
- The implementation of ICH E2E
- National adoption of ICH E2E
- Europe
- USA
- Japan
- Arab States
Outline of EU RMPs
- The current EU module V requirements
- Generic, innovator and advanced therapy products
- Additional documents to supply to the regulators
- Safety reporting timelines for RMPs
- EU RMP update and new requirements
The EU templates and their completion - generic and innovator products
- The EU generic template - EU requirements (module V)
- The EU generic RMP versus innovator RMP
- The EU template for innovator products
Completion of RMPs in other countries
The EU RMP and relationship with other documents
- The RMP post-authorisation safety and efficacy studies
- The RMP and PBRERs
- The RMP and safety reviews
The RMP and Risk Minimisation Follow up
Overview of the sections of the EU RMP template
- Part I - Product overview
- Part II - Safety specification modules SI-SVIII
- Part III - Pharmacovigilance plan including safety studies
- Part IV - Plans for post-authorisation efficacy studies
- Part V - Risk minimisation activities including effectiveness measures
- Part VI - Summary of the risk management plan
- Part VII - Annexes
Final discussion session
Speakers
Mr Graeme Ladds,
Director ,
PharSafer Associates Ltd.Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
Who Should Attend
This course will be relevant for those working in pharmacovigilance who are involved with writing RMPs, including medical directors/QPPVs who approve such plans. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, pre-clinical, sales and marketing, legal, commercial and quality.
