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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

Head of Business Capabilities and Innovation, Worldwide Patient Safety, Bristol-Myers Squibb Company
Jeremy is the Head, Business Capabilities and Innovation, Worldwide Patient Safety, for Bristol-Myers Squibb. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... 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. The main focus of the group currently is development of oncology/immune-oncology products. Ajay represents GSK on the TransCelerate work stream focused... Read More →
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 Chair of the TransCelerate Pharmacovigilance Steering Committee and as Merck's representative on the Clinical Trials... 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
  01: ClinSafety-PV, Session