The International Society for Pharmaceutical Engineering (ISPE) announced its 2020 ISPE Asia Pacific Pharma Manufacturing Virtual Conference & Executive Forum 21–23 September 2020. Now in its third year, this event brings together leaders from various offices under the Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss key trends, best practices, and regulatory perspectives for maintaining pharmaceutical supply chain continuity and compliance during and after the global pandemic.

“Manufacturing partners across geographic regions are navigating this new normal under stressful conditions exacerbated by increased demand for active pharmaceutical ingredients and essential medicines, new supply chain challenges, and the critical global focus on compliance and quality,” said Frances Zipp, President & CEO, Lachman Consultant Services, Inc., and Conference Co-Chair. “To truly continue to succeed as an industry, we must knowledge share and problem-solve together to mitigate the pharmaceutical supply chain impact of COVID-19 and proactively prepare for continued future success. That is what we will do during this collaborative event.”

“As pharmaceutical manufacturers reprioritize production due to changing and increased product demand, many don’t have alternate suppliers for critical components. This has been a game-changer as they not only have to identify new suppliers, but they must also qualify these components to ensure they understand impact on process, and that quality meets the required standards," said Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ, and Conference Co-Chair. “During this event, attendees will have the chance to ask questions to industry experts and regulators and hear what other companies are doing to overcome pandemic-driven challenges.”

Featured Regulatory Speakers:

Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

Letitia Robinson, PhD, Country Director, India Office, FDA/ORA

José Meléndez, Consumer Safety Officer, FDA/ORA

Chris Middendorf, International Relations Specialist (Drugs), FDA

Sarah McMullen, PhD, Deputy Director, Office of Compliance, FDA

Aditi Thakur, Acting Quality Assessment Lead, FDA/CDER/OPQ/OPF

Sudheendra Kulkarni, PhD, Medical Product Safety Coordinator, FDA/OC

Emily Thakur, CDR, Team Leader, Drug Shortages Staff, FDA

David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA

The 2020 ISPE Asia Pacific Pharma Manufacturing Virtual Conference & Executive Forum has been reimagined into a virtual experience that will immerse attendees in actionable, interactive discussions around strategies to make their manufacturing operations more agile, compliant, and resilient to disruption. Education sessions feature case studies and dedicated Q&A time with experts representing FDA, MHRA, local health authorities, Pfizer, Biocon, and more.

About ISPE

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.