Loading Events

« All Events

  • This event has passed.

Risk Management Plans – Europe and Beyond

September 22, 2016 @ 10:00 - 11:00 UTC+0

  • This webinar's live event will provide engaged attendees with 1 official Regulatory Affairs Recertification (RAC) Credit upon completion. 
  • Please note that attendees must request an official webinar participation certificate from Mapi Group to submit to RAPS in order to gain access to this educational training credit.

Webinar Topic:

Risk Management Plans – Europe and Beyond

Webinar Date & Time:

Thursday, September 22, 2016 at

  • 10:00 AM EST (New York, USA)
  • 3:00 PM GMT (London, UK)
  • 4:00 PM CET (Paris, FR)

Webinar Host:


Miranda Dollen, BSc (Hons) - Vice President, Pharmacovigilance at Mapi Group

  • Miranda started her career with a one year position in pharmacovigilance at the UK Medicines and Healthcare Products Regulatory Agency. Prior to joining Mapi, Miranda had 8 years’ experience in the pharmaceutical industry, with increasing responsibilities for the conduct of pharmacovigilance in the UK at Roche Products Ltd and Pharmacia Ltd.
  • Miranda Dollen has been with Mapi since June 2004, initially as a consultant specializing in European pharmacovigilance and providing the services of the EEA Qualified Person for Pharmacovigilance for a number of organizations. She became responsible for Mapi’s global pharmacovigilance operations in 2013, managing a dedicated team of pharmacovigilance professionals in Europe, USA and Canada. 
  • Miranda currently has responsibility for global pharmacovigilance and medical information consulting services provided to the pharmaceutical industry by Mapi and is currently working with multiple international clients to manage the challenge of the continually changing pharmacovigilance landscape.

Webinar Description:

A high level overview of the European regulatory requirements driving the format and content of Risk Management Plans and an introduction to requirements outside of Europe, including how to manage differing requests from different regulatory agencies.

This webinar may help those involved in writing Risk Management Plans, negotiating their content with regulatory agencies or conducting studies originating from a Risk Management Plan strategy.

Who should attend?

CEO’s, CTO’s, CIO’s, Presidents, VPs, Heads, Managers, Consultants, Directors, Scientific Advisors and professionals with intermediate to advance knowledge and experience in the following:

  • Pharmacoepidemiology
  • Pharmacogenomics
  • Drug/Product Safety
  • Information and Clinical
  • Data Management
  • Periodical safety update
  • Reports
  • Research & Development
  • Quality Assurance
  • Patient Safety
  • Signal Detection
  • Safety Surveillance
  • Epidemiology
  • Medical Affairs
  • Regulatory Affairs and Compliance
  • Information technology
  • Pharmacovigilance
  • Risk management
  • Drug Research & Development
  • Clinical Pharmacology
  • Clinical Safety
  • Information and Clinical Data Management
  • Medical product safety assessment
  • Clinical research & safety
  • Data analysis
  • Medical information
  • Health Outcomes Research

Register to attend now:



September 22, 2016
10:00 - 11:00
Event Category:
Event Tags:
, , , , , , , , , , , , , , , , , , , ,