FDA Vaccines Workshop 
ISPE
OCTOBER 27, 2022
You will get answers to the following questions: How were the fill-finish processes for the SARS CoV-2 vaccines developed and qualified, and how did the manufacturers manage to provide vaccine doses in such large quantities in such a short time? SARS CoV-2 vaccines have been formulated in lipid nanoparticles.
pharmaphorum
JANUARY 18, 2022
Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Guest FDA Speaker: John Barr Weiner, Associate Director for Policy and Product Classification Office, Office of Combination Products FDA. . POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. SMi’s 9th Annual Conference.
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ISPE
JUNE 27, 2023
The session included regulators from the European Medicines Agency (EMA), the UK Medicines & Healthcare Products, Regulatory Agency (MHRA), the Spanish Agency of Medicines and Medical Products (AEMPS) and the US Food and Drug Administration (FDA). In answer to the question, what does the industry have to do?
ISPE
SEPTEMBER 11, 2023
Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access.” “Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” Advanced Manufacturing.” 7 June 2023.
ISPE
MAY 9, 2023
Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.
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