4th Adverse Event Reporting and Safety Strategies Summit -

4th Adverse Event Reporting and Safety Strategies Summit
December 4 - 5, 2017
Philadelphia, PA

Harmonize and Comply with Adverse Event Management Regulations and Enhance Pharmacovigilance Strategies

Agenda – 4th Adverse Event Reporting and Safety Strategies Summit



Day One

 MONDAY, DECEMBER 4, 2017

CASE MANAGEMENT

8:30AM – 8:45AM

Chair Opening Remarks


Susan Welsh, Chief Safety Officer, CSL BEHRING

8:45AM – 9:45AM

Improve Product Safety With a Cohesive Company-Wide Approach


Stephen A. Goldman, Managing Member, STEPHEN A. GOLDMAN CONSULTING SERVICES; Former Medical Director, MEDWATCH, U.S. FOOD AND DRUG ADMINISTRATION

9:45AM – 10:30AM

Improve Efficiency, Safety, and Compliance Through Strategic Selection, Management, and Oversight of Vendors


Judith Sills, Vice President and Head, Global Pharmacovigilance, THE MEDICINES COMPANY

10:30AM – 11:15AM

Engage PV Vendors: Experience of a Small Biotech


Bill Haddock, Head of Safety, OVID THERAPEUTICS

11:15AM – 11:30AM

Networking Break


11:30AM – 12:15PM

Implement an Effective CAPA System in Pharmacovigilance


Deepa Arora, VP Pharmacovigilance and Global Head Drug Safety and Risk Management, LUPIN LIMITED

12:15PM – 1:00PM

Luncheon


1:00PM – 1:45PM

Ascertain Hidden SAEs/SUSARs in Endpoint Reports by Systematizing and Standardizing a Process


Ghazala Haque, Safety Surveillance Manager, DUKE UNIVERSITY MEDICAL CENTER

1:45PM – 2:30PM

Case Study: CSL Behring’s Model for Embedded Vendor Collaboration to Supplement Case Management


Joanne Grego, Global Vendor Management and ICSR Quality Lead, GCSP, CSL BEHRING
Richard Wolf, Head, GCSP Regions and PV Operations, CSL BEHRING

2:30PM – 3:00PM

Networking Break


 SIGNAL MANAGEMENT AND ASSESSMENT

3:00PM – 3:45PM

Improve Signal Management and Drug Safety by Preempting or Responding to Causes of AE in Manufacturing


Paul Beninger, Assistant Professor of Public Health and Community Medicine, Tufts University School of Medicine; Former Vice President, Global Patient Safety, GENZYME

3:45PM – 4:30PM

Utilize Real-Word Data From Social Media and Other Sources for Signal Detection


Andres Gomez, Vice President, Head of Epidemiology, Safety Science and Analytics, BRISTOL-MYERS SQUIBB

4:30PM – 5:15PM

Determine Your Global Signal Management Strategy


Michael von Forstner, Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE


Day Two

 TUESDAY, DECEMBER 5, 2017

DATA SCIENCE AND TECHNOLOGY

8:00AM – 9:15AM

Continental Breakfast


9:15AM – 9:30AM

Chair Recap of Day One


Susan Welsh, Chief Safety Officer, CSL BEHRING

9:30AM – 10:15AM

Automation of Adverse Events Reporting and Artificial Intelligence Application


Israel Gutierrez, Senior Director Drug Safety and Pharmacovigilance, PHARMACYCLICS

10:15AM – 11:00AM

Use Artificial Intelligence to Enhance Safety Operations: Currently Available and Upcoming Technology


Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

11:00AM – 11:30AM

Networking Break


11:30AM – 12:30PM

Panel: Harness New Technologies for PV


Panelists
Israel Gutierrez, Senior Director Drug Safety and Pharmacovigilance, PHARMACYCLICS
Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

12:30PM – 1:30PM

Luncheon


 AUDITS AND INSPECTION TRENDS

1:30PM – 2:15PM

Ensure Inspection Readiness Through Mock Inspections


Deanna Montes de Oca, Associate Director, PV Operations Clinical Safety and Pharmacovigilance, OTSUKA

2:15PM – 3:00PM

Comply With the FDA’s June 2018 Deadline for Combination Product Safety Reporting


Gay Steinbrick, Director, Global Clinical Safety and Pharmacovigilance, MERCK

3:00PM – 3:15PM

Chair Closing Remarks


Susan Welsh, Chief Safety Officer, CSL BEHRING


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