Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Michal Forstner-Dambenois
OVERVIEW:
Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.
Such RMPs nowadays constitute an important part of the registration package of a new drug and are frequently also required for established drugs, in particular when these are submitted for new indications. Failure to provide high quality RMPs can lead to substantial delays in approvals of new drugs or can result in unreasonable requirements by the health authorities in order to have the product approved. In this webinar, we are going to cover the risk management planning cycle at a high level to gain an understanding of what fundamental steps are necessary in risk management throughout a product’s lifecycle. The session will only touch briefly upon legal requirements but rather focus on the overarching goals of RMPs.
Why should you Attend: Risk Management Plans have become a central document in the approval process for new therapeutic drugs and are designed to describe the means by which a marketing authorization holder plans to establish and maintain a favorable benefit-risk balance of the drug. A large proportion of RMPs submitted to health authorities do not or only partially meet the requirements for a successful approval, resulting in costly delays. This webinar aims to give an overview of which planning steps should be taken and why, in order to obtain a high quality RMP.
Areas Covered in the Session:
– Identifying Issues
– Assessing key risk areas
– Measuring impact and likelihood of risks
– Ranking Risks
– Setting Desired Results
– Developing Options
– Selecting a Strategy
– Implementing the Strategy
– Measuring effectiveness of risk minimization and adjusting the activities
Who Will Benefit:
– Pharmacovigilance professionals
– Drug Safety Scientists
– Safety Physicians
– Regulatory Affairs Managers and Leaders
– Medical Affairs Staff
– Clinical Development Leaders
SPEAKER PROFILE:
Michal Forstner-Dambenois has 17 years experience in the pharmaceutical industry in R&D and Drug Safety, most recently heading the European PV department of a large international pharmaceutical company with the responsibility to establish and maintain a compliant and high-performance PV system in all EU and non-EU countries, including Russia/CIS and Israel. Led the introduction of integrated risk management planning and the new EU-RMP process in a global PV organization, including development of RMP implementation processes and methods for the evaluation of effectiveness of risk minimization. Vast experience in the application of risk and benefit-risk analysis methodologies on pharmaceutical products and processes. Subject matter expert in drug safety issue and crisis management. Experience in auditing/QC monitoring of PV systems at the global, regional and local level, as well as experience as host and/or SME in regulatory authority inspections.
