Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

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Session 5: Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

Session Chair(s)

Barbara Morollo, RN

Head, Pharmacovigilance, Corbus Pharmaceuticals, United States

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues, or cells. As such, ATMPs can be classified into three main types:

Gene therapy medicines that contain genes that have a therapeutic, prophylactic, or diagnostic effect

Somatic-cell therapy medicines that contain cells or tissues that have been manipulated to change their biological characteristics such that they can be used to cure, diagnose, or prevent diseases

Tissue-engineered medicines that contain cells or tissues that have been modified so they can be used to repair, regenerate, or replace human tissue This session will examine the evolving Pharmacovigilance and Risk Management landscape concerning ATMPS, and will examine the challenges of conducting meaningful product surveillance and developing patient-central risk minimization plans in the setting of advanced therapies. This session will also explore the concept of conducting benefit-risk assessments in the gene therapy setting and will also spend time discussing the potential impact of the EMA’s draft guidance on safety and efficacy follow-up and risk management of Advanced Therapeutics which was released in February 2018.

Learning Objective : Upon completion of this session, the participant should be able to:
Describe why the approach to pharmacovigilance, including signaling with ATMPs is different from other pharmaceutical products
Understand the complexities involved in determining the benefit-risk assessment of an ATMP
Be familiar with the new draft guidance on safety and efficacy follow-up and risk management of Advanced Therapeutics

Speaker(s)

Adamma Mba-Jonas

Chief Medical Officer, CBER, FDA, United States

Barbara Morollo, RN

Head, Pharmacovigilance, Corbus Pharmaceuticals, United States

Jan Petracek, MD, MSC

CEO, iVigee Services a.s., Czech Republic

David Chonzi

Vice President, Head of PV and Epidemiology, Allogene Therapeutics, United States

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Pharmacovigilance and Risk Management Strategies Conference

Session 5: Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

Session Chair(s)

Barbara Morollo, RN

Speaker(s)

Adamma Mba-Jonas

Barbara Morollo, RN

Jan Petracek, MD, MSC

David Chonzi

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