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Periodic Benefit Risk Evaluation Reports – Tips and Hints

October 25, 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:

Periodic Benefit Risk Evaluation Reports – Tips and Hints

Webinar Date & Time:

Tuesday, October 25, 2016 at

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

Webinar Host:


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

  • 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.
  • 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 started her career with a one year position in pharmacovigilance at the UK Medicines and Healthcare Products Regulatory Agency.
  • Miranda Dollen currently has responsibility for global pharmacovigilance and medical information consulting services provided to the pharmaceutical industry by Mapi. She is working with multiple international clients to manage the challenge of the continually changing pharmacovigilance landscape.


A discussion of the challenges of preparing Periodic Benefit Risk Evaluation reports in a global environment, the impact of different regional regulatory requirements, and managing the multiple functional areas involved in report preparation. This webinar may help those involved in writing, contributing, reviewing, or approval of Periodic Benefit Risk Evaluation Reports.

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 now: