GHC meeting Feb 10 2023, Joint GH/RS Webinar CAR T- March 16 12:30-2pm ET

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GHC meeting Feb 10 2023, Joint GH/RS Webinar CAR T- March 16 12:30-2pm ET

1. GHC meeting Feb 10 2023, Joint GH/RS Webinar CAR T- March 16 12:30-2pm ET

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Sai Sumana Penumetcha

Posted 02-10-2023 17:47

Hi All,

In follow up to our meeting today, and finalizing the logistics to the joint webinar between Regulatory & Global health community, here are the topics shared with Dr. Sandro Matosevic earlier.

1) Topics for Webinar

CAR T-cell therapies R&D
An example of a drug through its regulatory pathway
Approved Drugs
History of these therapies
Current global access in different countries
R&D in different countries
Global health aspects

Joleen suggested

Challenges in clinical development and regulatory approval of CART in the global environment beyond US and EU

Please add in any other ideas that can be shared to the speaker from a Global health & Regulatory perspective so that we can close the webinar submission form soon.

2) Moderators.

Chris will moderate and Sudip will support from the Global Health Team.

They will also attend the Regulatory community meeting Feb 17th to follow up on the joint webinar.

3) Promotion

Once we have the webinar submission form ready, request all of you to share the flyer that Chris will have ready to your professional networks.

4) Webinar Submission form

Additional communities that Joleen has suggested in webinar submission form are below.

You may please share the webinar schedule to other communities that you think will be interested in the topic.

	Bioanalytical		Patient-Centric Community (this one is retired)
	Bioequivalence		Personalized Medicine
	Biomarkers & Precision Medicine		Pharmaceutical Discovery and Preclinical Development
	Biopharmaceutical Product Attributes and Biological Consequences		Pharmaceutical Impurities
	Biosimilar Development, Strategy, and Implementation		Pharmaco-Imaging
	Chemical and Biological Active Pharmaceutical Ingredient		Pharmacometrics
	Chemistry, Manufacturing, and Controls (CMC)		Pharmacokinetics, Pharmacodynamics, & Drug Metabolism
	CMC Statistics		Predictive Modeling
	Drug Metabolism and Biologics Disposition		Preformulation & Formulation Design/Development
	Drug Transport		Process Analytical Technology
	Excipients		Process Modeling and Simulation
	Gene and Cell Therapy Products		Protein Purification, Storage, and Transportation
	Generic Pharmaceuticals		QBD and Product Performance
	Global Health		Regulatory Sciences
	In Vitro Release and Dissolution Testing		Stability
	Inhalation and Nasal		Sterile Products
	Lipid-Based Drug Delivery Systems		System Compliance and Technology Solutions
	Manufacturing Science and Engineering		Systems Pharmacology
	Modified Release		Targeted Drug Delivery and Prodrugs
	Nanotechnology		Therapeutic Product Immunogenicity
	Nutraceuticals and Natural Products		Tissue Monitoring Technologies
	Ocular Drug Delivery and Biopharmaceutics		Topical and Transdermal
	Oral Biopharmaceutics and Absorption Modeling		Veterinary Pharmaceutics, Biologics and Technology
	Outsourcing		Women in Pharmaceutical Science
	Other:

Thank you.

Sincerely,

Sumana

On Wed, Feb 8, 2023 at 8:00 PM Das, Sudip <[email protected]> wrote:

Please use this Zoom link. Thanks

Join Zoom Meeting
https://butleru.zoom.us/j/3630677053

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GHC meeting Feb 10 2023, Joint GH/RS Webinar CAR T- March 16 12:30-2pm ET

1. GHC meeting Feb 10 2023, Joint GH/RS Webinar CAR T- March 16 12:30-2pm ET