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SPA REGULATORY WORKSHOP
August 24-25, 2016
Buchanan, Ingersoll & Rooney Office
1700 K Street, N.W., Suite 300  Washington, DC 20006-3807

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Agenda for the 2016 SPA Regulatory Workshop:

Wednesday, August 24th

Meeting from 1:00 PM to 4:30PM covering the following topics:

·         1:00 pm – 2:00 pm – The DSCSA Regulations: How they Affect Business Strategy (including compliance, implementation, etc.) presented by Barbara Binzak (http://www.bipc.com/Barbara-A-Binzak/ )

·         2:00 pm – 2:15 pm – Networking Break

·         2:15 pm –3:15 pm – Litigation and FDA regulated products: understanding your rights and options presented by Lloyd Smith (http://www.bipc.com/S-Lloyd-Smith/ )

·         3:15 pm – 3:30 pm – Networking Break

·         3:30 pm – 4:30 pm – 2016-17 Federal Update & Forecast presented by Mike Strazzella (http://www.bipc.com/Michael-P-Strazzella/ )

5:00 PM dinner at Kellari Taverna (Right next to the law offices and this is included in your registeration fee) http://kellaridc.com/

 

Thursday, August 25th

Meeting from 8:30 am to 12:00 pm covering the following topics:

·         8:30 am –9:30 am – Coverage and pricing issues related to drugs, medical foods, and dietary supplements presented by Tom Evegan    https://specialtypharma.org/content.asp?id=1542543

·         9:30 am –9:45 am – Networking Break

·         9:45 am –10:45 am – Quality Agreements 101 presented by Robin Dierbeck – (http://www.bipc.com/Robin-L-Dierbeck/ )

·         10:45 am – 11:00 am–- Networking Break

·         11:00 am – 12:00 pm – FDA and Antitrust update: FDA Update (including drug takeback issues, litigation, product approvals, etc.), Antitrust update (distribution/supply agreements, REMS, M&A and product hopping) presented by William Garvin (http://www.bipc.com/William-A-Garvin/) and Carrie Amezcua (http://www.bipc.com/Carrie-G-Amezcua/ )

Afterwards you are encouraged to go and visit your Congressmen/women.

Sponsors for the 2016 Regulatory Workshop

Gold

 


 

 

WOODFIELD PHARMACEUTICAL, LLC

 

 

 

Silver


 

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