A Practical Guide to Writing Risk Management Plans – CPD Accredited Online Training Course

DUBLIN, Nov. 27, 2023 /PRNewswire/ — The “A Practical Guide to Writing Risk Management Plans (RMPs) Training Course”  has been added to ResearchAndMarkets.com’s offering.

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 maintenanceClarify the documentation to be supplied to regulators and the process for RMPsLearn what happened in the EU RMP update and explore the new requirementsDiscuss the EU templates and their completion – generic and innovative productsUnderstand the relationship between RMPs, post-authorisation safety and efficacy studies, safety reviews and PBRERsDiscuss the RMP and risk minimisation follow-up

Certification:

CPD: 6 hours for your recordsCertificate of completion

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.

Course Agenda:

An introduction to RMPs

Outline and purpose of ICH E2EThe implementation of ICH E2ENational adoption of ICH E2EEuropeUSAJapanArab States

Outline of EU RMPs

The current EU module V requirementsGeneric, innovator and advanced therapy productsAdditional documents to supply to the regulatorsSafety reporting timelines for RMPsEU 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 RMPThe 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 studiesThe RMP and PBRERsThe RMP and safety reviews

The RMP and Risk Minimisation Follow up

Overview of the sections of the EU RMP template

Part I – Product overviewPart II – Safety specification modules SI-SVIIIPart III – Pharmacovigilance plan including safety studiesPart IV – Plans for post-authorisation efficacy studiesPart V – Risk minimisation activities including effectiveness measuresPart VI – Summary of the risk management planPart VII – Annexes

Final discussion session

For more information about this conference visit https://www.researchandmarkets.com/r/af9llp

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected] 

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg

 

View original content:https://www.prnewswire.com/news-releases/a-practical-guide-to-writing-risk-management-plans—cpd-accredited-online-training-course-301997962.html

SOURCE Research and Markets