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Monday, June 25 • 11:00am - 12:15pm
#106: Signal Management: Separating Needles From Haystacks

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-519-L04-P; CME 1.25; IACET 1.25; RN 1.25

The session will discuss signal management throughout the lifecycle and how to transition from the pre-approval to the post approval setting. In the post-approval setting, we will concentrate on signal management requirements in EudraVigilance and provide some examples of how companies are addressing the requirements.
The speakers have broad experience and represent the perspectives of CROs, large pharma and small biotech companies.

Learning Objectives

Describe the key elements of a signal management process throughout the lifecycle; Identify the requirements of signal management in EudraVigilance and formulate best practices.

Chair

William Gregory, PhD

Speaker

Experiences with the EVDAS Requirements
Uwe Trinks

From Clinical Trial to Post-Marketing Signal Management: A Continuum
Rosa A. Piccirillo, MD

Latest Initiatives with Signal Detection and Management at MHRA
Mick Foy


Speakers
avatar for Mick Foy

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
RP

Rosa Piccirillo

Senior Director and Global Head, Medical Safety, Core Safety Services, IQVIA
Dr. Piccirillo is a Sr. Director Medical Safety at IQVIA. Dr. Piccirillo has experience in clinical trial development and implementation, with special focus on safety reviews, post-marketing surveillance, signal detection, risk management, reference safety information review-updates... Read More →
UT

Uwe Trinks

Partner and Director, Foresight Group, An IQVIA Company
Dr. Trinks is a Partner at Foresight Group International AG with 30 years of experience in Pharmaceutical R&D holding senior postions in R&D IT at Ciba-Geigy and Novartis and as CIO of Sentrx. He received a PhD in organic chemistry from the Swiss Federal Institute of Technology (ETH... Read More →

Monday June 25, 2018 11:00am - 12:15pm
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session