The health and safety of the PCPV summit registrants is our number one priority. Due to the uncertainty of the impact of COVID-19, we have made the difficult decision to postpone the PCPV Summit to Sept. 2023. In the interim, we will be launching a speaker series discussing PV challenges with PCPV Summit speakers and PCPV Board members. Be sure to click Stay Informed below for more updates about the speaker series and PCPV Summit 2023.

Speakers Series

Practical Approaches to Product Level Safety Planning for Clinical Development Programs by the DIA-ASA (ASAP) Task Force.

Dr. Jim Buchanan, President at Covilance, LLC, and co-chair of the American Statistical Association (ASA) Biopharmaceutical Safety Working Group, talks with Dr. Barbara Hendrickson, Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety at AbbVie, about practical approaches to product level safety planning for clinical development programs proposed by the DIA-ASA Aggregate Safety Assessment Plan (ASAP) Task Force. Dr. Hendrickson outlines a step by step process for aggregate safety analysis that can be applied to any clinical development program. Following this short presentation, Dr. Buchanan engages Dr. Hendrickson in an intriguing Q&A session discussing some of the complexities of an ASAP approach and how the ASAP efforts can ultimately help mitigate downstream safety concerns.

For more information about the DIA-ASA Task Force, visit https://community.amstat.org/biop/workinggroups/safety/safety-home.

Dr. James Buchanan

President
Covilance LLC

Dr. Barbara Hendrickson

Immunology Therapeutic Area Head Pharmacovigilance and Patient Safety
AbbVie

DILI Pearls: CIOMS DILI WG: A Conversation with Dr. Javier Waksman

Dr. Javier Waksman, the Vice-President of Drug Safety at Sangamo Therapeutics speaks with Bethany Van Veen, CEO and founder of Perspective Pharmacovigilance, about the recent Drug Induced Liver Injury (DILI) CIOMS Working Group publication. Dr. Waksman offers practical solutions for the identification, characterization, and management of DILI during development, as well as after product launch. He describes the CIOMS Working Group’s overall objectives and what challenges they faced while developing the publication. Dr. Waksman also discusses the advancements he believes are on the horizon regarding DILI from a clinical, pharmacovigilance, and regulatory standpoint.

Bethany Van Veen

CEO and Founder
Perspective Pharmacovigilance, Inc.

Dr. Javier Waksman

Vice President, Head of Drug Safety
Sangamo Therapeutics, Inc.

Navigating an MHRA GCP Reference Safety Information (RSI) Office Based Inspection (OBI): An Interview with Evan Blander

Bethany Van Veen, CEO and founder of Perspective Pharmacovigilance, discusses Exelixis’ first ever virtual MHRA GCP inspection with Evan Blander, Vice-President of Drug Safety at Exelixis. Evan describes the unique challenges to this new virtual inspection concept; everything from building rapport with inspectors to modifying traditional inspection SOPs to asking the question, ‘does a War Room still make sense when everyone is remote?’ Evan offers practical advice to other companies who may be preparing for an upcoming inspection and reflects on what he and his team may have done differently to make the inspection process more seamless and effective.

Bethany Van Veen

CEO and Founder
Perspective Pharmacovigilance, Inc.

Evan Blander

Vice President, Drug Safety
Exelixis, Inc.

Practical Approaches to Product Level Safety Planning for Clinical Development Programs by the DIA-ASA (ASAP) Task Force.

Dr. Jim Buchanan, President at Covilance, LLC, and co-chair of the American Statistical Association (ASA) Biopharmaceutical Safety Working Group, talks with Dr. Barbara Hendrickson, Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety at AbbVie, about practical approaches to product level safety planning for clinical development programs proposed by the DIA-ASA Aggregate Safety Assessment Plan (ASAP) Task Force. Dr. Hendrickson outlines a step by step process for aggregate safety analysis that can be applied to any clinical development program. Following this short presentation, Dr. Buchanan engages Dr. Hendrickson in an intriguing Q&A session discussing some of the complexities of an ASAP approach and how the ASAP efforts can ultimately help mitigate downstream safety concerns.

For more information about the DIA-ASA Task Force, visit https://community.amstat.org/biop/workinggroups/safety/safety-home.

Dr. James Buchanan

President
Covilance LLC

Dr. Barbara Hendrickson

Immunology Therapeutic Area Head Pharmacovigilance and Patient Safety
AbbVie

DILI Pearls: CIOMS DILI WG: A Conversation with Dr. Javier Waksman

Dr. Javier Waksman, the Vice-President of Drug Safety at Sangamo Therapeutics speaks with Bethany Van Veen, CEO and founder of Perspective Pharmacovigilance, about the recent Drug Induced Liver Injury (DILI) CIOMS Working Group publication. Dr. Waksman offers practical solutions for the identification, characterization, and management of DILI during development, as well as after product launch. He describes the CIOMS Working Group’s overall objectives and what challenges they faced while developing the publication. Dr. Waksman also discusses the advancements he believes are on the horizon regarding DILI from a clinical, pharmacovigilance, and regulatory standpoint.

Dr. Javier Waksman

Vice President, Head of Drug Safety
Sangamo Therapeutics, Inc.

Bethany Van Veen

CEO and Founder
Perspective Pharmacovigilance, Inc.

Navigating an MHRA GCP Reference Safety Information (RSI) Office Based Inspection (OBI): An Interview with Evan Blander

Bethany Van Veen, CEO and founder of Perspective Pharmacovigilance, discusses Exelixis’ first ever virtual MHRA GCP inspection with Evan Blander, Vice-President of Drug Safety at Exelixis. Evan describes the unique challenges to this new virtual inspection concept; everything from building rapport with inspectors to modifying traditional inspection SOPs to asking the question, ‘does a War Room still make sense when everyone is remote?’ Evan offers practical advice to other companies who may be preparing for an upcoming inspection and reflects on what he and his team may have done differently to make the inspection process more seamless and effective.