CAPRA Dinner Meeting in Montreal, Thursday, June 26th, 2014
Submission of Risk Management Plans and Follow-up Commitments
Speaker: Rania Mouchantaf, PhD, RA/ Manager, Marketed Pharmaceuticals and Medical Devices
Description: Regulators around the world have expanded their investment and policy frameworks in the development of tools to asses both pre- and post-market safety evidence. These efforts have expanded with the implementation of a number of International Conference on Harmonisation (ICH) guidelines including ICH E2E Guideline.
Objectives of the recently released Risk Management Plans (RMPs) guidance document: Submission of Risk Management Plans and Follow-up Commitments for stakeholder consultation include providing stakeholders with guidance on how to proceed when submitting an RMP in the European Union (EU) format or its equivalent (e.g., United State (US) Risk Evaluation and Mitigation Strategy [REMS]), as well as follow-up commitments and updates with Health Canada.
Last networking opportunities before the summer holidays:
Follow the link to register: http://www.capra.ca/meetings_register_june26_2014.html
*** DEADLINE: Tuesday, June 24th, 2014 4pm ***