Course 1: PBRER
Melissa Chan, PharmD
- Aggregate Report Analyst, Safety Evaluation and Reporting
- Pfizer, United States
Melissa Chan graduated from The University of Tennessee Health Science Center with a Pharm.D. and pursued a 1-year postgraduate pharmacy residency at Kingsbrook Jewish Medical Center in Brooklyn, New York. She joined Pfizer in 2011 and currently works as an aggregate report analyst in the Safety Evaluation and Reporting department.
Valerie E. Simmons, MD, FFPM
- EU QPPV, Global Patient Safety
- Eli Lilly and Company Ltd, United Kingdom
Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Committee, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management
Alison Turney, PharmD
- Surveillance Business Process Advisor, Global Patient Safety
- Eli Lilly and Company, United States
Alison Turney, PharmD Dr. Turney is a Surveillance Business Process Advisor in Global Patient Safety (GPS) at Eli Lilly and Company. She is responsible for coordination of activities and processes within GPS and between GPS and global and local functions within the company to maintain compliance with regulatory requirements worldwide. Alison has over 15 years of experience in Pharmacovigilance and is responsible for the strategy and development of processes to enable appropriate characterization and communication of the benefit risk balance of products for patients including Post-Marketing Safety Surveillance, the Development Safety Update Report (DSUR) and the Periodic Benefit Risk Evaluation Report (PBRER).
Other Preconference Short Courses
Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs
Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking