ISPE Assembles Global Health Authorities to Discuss COVID-19 Challenges & Industry-Critical Topics

22 October, 2020

ISPE announced its 2020 ISPE Annual Meeting & Expo, taking place virtually 2–6 November 2020, will feature an unprecedented number of regulators representing a diverse mix of global health authorities providing insights on COVID-19 and other industry-critical topics.

Stephen Hahn, MD

The latest addition to the speaker line-up is Stephen Hahn, MD, Commissioner, USFDA, who will deliver a keynote presentation during a gathering of the Global Pharmaceutical Manufacturing Leadership Forum and the ISPE Annual Member Meeting during the conference. Dr. Hahn was sworn in as the 24th Commissioner of the USFDA on 17 December 2019. He is a dedicated clinician, having trained in both medical oncology and radiation oncology.

Amy Abernethy, MD, PhD
Principal Deputy Commissioner

Keynote speaker Amy Abernethy, MD, PhD, Principal Deputy Commissioner, FDA, will return to this leading forum to share new insights and perspectives during her Keynote Fireside Chat.

“The COVID-19 pandemic has placed a spotlight on the need for regulatory agencies and pharmaceutical companies to work closely to ensure the development of safe, effective, and high-quality medicines," said Tom Hartman, President & CEO, ISPE. “This event brings the industry and regulators together to have timely discussions and exchange thoughts openly in a ‘conversational, safe forum,’ which ultimately helps to advance the pharmaceutical industry's mission.”

Additional Featured Regulators:

Lucinda F. Buhse, PhD
Acting Senior Advisor for OPQ
Melissa B. Burns
Senior Program Manager, Office of Combination Products
David Churchward
Deputy Unit Manager, Inspectorate Strategy & Innovation
Jeannie C. David
Senior Program Management Officer, Drug Shortages Staff
Matthew JH Davis
Senior GMP Inspector
Therapeutic Goods Administration
Richard L. Friedman
Deputy Director, Science & Regulatory Policy
Joey Gouws, PhD
Team Lead, Inspection Services, Prequalification Team
World Health Organization
Paul A. Gustafson
Senior Corporate Regulatory Compliance & Enforcement Advisor, PIC/S Deputy Chair
Regulatory Operations and Regions Branch (RORB), Health Canada
Steven Hertz, MS, MBA, PE
Consumer Safety Officer, Office of Pharmaceutical Quality
Jennifer Maguire, PhD
Acting Director
Gustavo Mendes Lima Santos
General Office of Medicines and Biological Products
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Tracy Moore
GMDP Operations Manager
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Abdelaali Sarakha, PhD
Senior GMP Inspector, Annex 1 Rapporteur
French Health Products Safety Agency (ANSM)
Seneca D. Toms, MS, RAC
Biotechnology Drug Specialist Investigator
U.S. Food and Drug Administration (FDA)

The 2020 ISPE Annual Meeting & Expo has been reimagined into a virtual experience that will immerse attendees in actionable discussions around industry-critical initiatives—focusing on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. Education sessions feature case studies and dedicated Q&A time with experts. In addition to global health authorities, speakers represent a diverse mix of industry stakeholders, including AstraZeneca, Eli Lilly, Kite Pharma, GSK, Vetter Pharma, and more.

Explore Agenda & Register