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A Pharmacovigilance Webinar on The new European Risk Management Plan
November 9, 2017 @ 10:00 - 11:00 UTC+0
Miranda Dollen - Vice President, Pharmacovigilance, Mapi Group
In March 2017 the EMA released a new template for the European Risk Management Plan (RMP). There are extensive changes throughout the template and a new concept introduced justifying why an identified or potential risk is not included in the list of safety concerns in the RMP. Existing European RMP will need to be converted into the new format on their next submission after 30-Mar-2018. This webinar will review the primary differences between the new and old European RMP templates and discuss challenges that may be faced by organisations going through this transition.