A Practical Guide to Writing Risk Management Plans (London, United Kingdom - June 29, 2020) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "A Practical Guide to Writing Risk Management Plans" conference has been added to ResearchAndMarkets.com's offering.

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.

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.

The programme has been fully revised to include the latest updates.

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
• Discuss the EU templates and their completion - generic and innovator products
• Understand the relationship between RMPs, post-authorisation safety and efficacy studies, safety reviews and PBRERs
• Discuss the RMP and risk minimisation follow-up
  

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

Outline of EU RMPs

• EU module V requirements
• Generic, innovator and advanced therapy products
• Additional documents to supply to the regulators
• Safety reporting timelines for RMPs

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

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

Overview of the sections of the EU RMP template (continued)

• 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

For more information about this conference visit https://www.researchandmarkets.com/r/pn0hkp