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.
NORTH BETHESDA, Md. (PRWEB) October 22, 2020
The International Society for Pharmaceutical Engineering (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.
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.
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 Buhse, PhD, Acting Senior Advisor, Office of Pharmaceutical Quality, CDER/FDA
- Melissa Burns, Senior Program Manager, Office of Combination Products, CDER/FDA
- David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, Medicines and Healthcare products Regulatory Agency (MHRA)
- Jeannie David, Senior Program Management Officer, Drug Shortages Staff, CDER/FDA
- Matt Davis, Senior GMP Inspector - Inspections Team Leader, Therapeutic Goods Administration (TGA)
- Richard Friedman, Deputy Director, Science & Regulatory Policy, CDER/FDA
- Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization (WHO)
- Paul Gustafson, Senior Corporate Regulatory Compliance and Enforcement Advisor, Regulatory Operations and Regions Branch (RORB), Health Canada, PIC/S Deputy Chair
- Steven Hertz, MS, MBA, PE, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER/FDA
- Jennifer Maguire, PhD, Acting Director, Office of Quality Surveillance, CDER/FDA
- Gustavo Mendes Lima Santos, General Office of Medicines and Biological Products, GGMED, National Health Surveillance Agency (ANVISA)
- Tracy Moore, GMDP Operations Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
- Abdelaali Sarakha, Inspector, French Health Products Safety Agency (ANSM), Annex 1 Rapporteur
- Seneca D. Toms, Biotechnology Specialist Investigator, ORA/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.
To explore the education agenda and to register, please visit ISPE.org/AM20.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.
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International Society for Pharmaceutical Engineering (ISPE)