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The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity in the supply chain in light of this crisis and assuring preparedness for future crises will be integrated throughout the conference agenda, panel discussions, and accompanying workshops.
NORTH BETHESDA, MD. (PRWEB)
July 15, 2021
The International Society for Pharmaceutical Engineering (ISPE) announced a world-class line-up of eight leading biotech experts as keynote presenters for the 2021 ISPE Biotechnology Virtual Conference & Workshop. Taking place 22-24 September 2021, this unparalleled fully interactive virtual event will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share knowledge, and provide an outlook on the evolving landscape and future of biopharmaceutical manufacturing and therapies.
“This year, in particular, the industry rallied together to innovate at record speed and partnered in ways that were unprecedented to address not only the public health crisis brought on by the pandemic, but also to ensure patients worldwide would continue to have access to necessary therapies,” said Program Co-Chair David Doleski, Head of Global Quality Audit, Sanofi. “This conference will help prepare biopharmaceutical professionals and their organizations for the impact of innovations in biologics that will influence their operations and shape the future.”
Keynote presenters will kick off day one of the conference with presentations on industry-critical topics such as regulatory aspects for advanced therapy medicinal products (ATMPs), cell and gene therapies, and COVID-19 therapies and vaccines. Then they will come together for a compelling panel discussion.
Keynote Presenters:
Matthew JH Davis
Senior GMP Inspector
Therapeutic Goods Administration
Raj Puri
Director, Division of Cellular and Gene Therapies
CBER/FDA
Wilson Bryan
Director, Office of Tissues and Advanced Therapies
CBER/FDA
Francesco Cicirello
Director, Quality Assurance
Evelo Biosciences
Jessica Beyer
Director, Cell Therapy Manufacturing
Bristol Myers Squibb
Oliver Henning
Senior Vice President Operations
BioNTech SE
Rino Rappuoli
Chief Scientist
GSK
Sandy Douglas
Academic Clinician
University of Oxford
The ISPE Biotechnology Virtual Conference & Workshop is a leading interdisciplinary forum for all stakeholders of the pharmaceutical and biopharmaceutical value chain to unite and learn about the latest innovations and trends, and openly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective.
Event exclusives include plant tours featuring state-of-the-art facilities and two in-depth workshops. Workshop participants will be presented with a case study and practice finding solutions with the help of trainers. Topics include control strategy, technology transfer, CMC, computer-based modeling, ATMPs, facility design, and GXP compliance.
“The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity in the supply chain in light of this crisis and assuring preparedness for future crises will be integrated throughout the conference agenda, panel discussions, and accompanying workshops,” said Program Co-Chair Prof. Dr. Michelangelo Canzoneri, Global Head of Digital and Data, Healthcare, Merck KGaA, Darmstadt, Germany.
To explore the educational agenda and to register, please visit ISPE.org/Bio21.
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 18,500 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.
For more information, contact:
Amy Henry
Marketing Communications Manager
International Society for Pharmaceutical Engineering (ISPE)
Email: ahenry@ispe.org
ISPE.org
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