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Monday, June 25 • 3:00pm - 4:15pm
#139: Novel Approaches to Pharmacovigilance Collaboration

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

Following the success of its clinical initiatives, TransCelerate launched its first pharmacovigilance projects in 2017, which are now actively engaging with health authorities and delivering both near-term and long-term value. This session will feature a panel of leaders from TransCelerate’s pharmacovigilance teams, as they discuss the future of pharmacovigilance (challenges associated with globalization, data automation, new PV requirements, etc.) and discuss initiatives that TransCelerate has undertaken to address these challenges.

Learning Objectives

Describe expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges.

Chair

Jose Vega, MD

Speaker

Industry Collaboration to Improve Patient Safety: TransCelerate’s Long-Term Vision to Address Pharmacovigilance Challenges
Jose Vega, MD

Evaluating the Value of Safety Information Data Sources: Gathering Evidence to Illustrate a Hierarchy of Value
Peter Verdru, MD

Interpretation of PV Regulations
Ajay B. Singh, MD

Value of Safety Information Data Sources
Jeremy Jokinen

FDA Perspective
Gerald J. Dal Pan, MD, MHS



Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Senior Director, Decision Sciences, AbbVie, Inc.
Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel approaches and methodologies to improve patient safety. Jeremy has over 20 years... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, FDA
Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both... Read More →
AS

Ajay Singh

Team Leader, Safety Evaluation and Risk Management, GlaxoSmithKline
Ajay is a nephrologist by training and currently serves as a team leader in the Safety Evaluation and Risk Management group at GSK.
avatar for Jose Vega

Jose Vega

Vice President, Chief Safety Officer, Merck & Co., Inc.
José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Executive Sponsor of the TransCelerate Pharmacovigilance initiatives and as Merck's representative on the Clinical... Read More →
avatar for Peter Verdru

Peter Verdru

Vice President, Head of Patient Safety, UCB Biopharma S.P.R.L.
Peter Verdru, MD was trained as neurologist and joined UCB in 1997. He is heading the global Patient Safety team since 2015. Prior to his current role, Peter was heading the Therapeutic Area CNS in Medical Affairs and Clinical Development.


Monday June 25, 2018 3:00pm - 4:15pm
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA