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2017 Regulatory Workshop Agenda

Specialty Pharma Association Regulatory Workshop

 August 23-24, 2017

Wednesday, August 23

1:00 – 2:00 pm | OTC Monograph Reform and User Fees

  • Presented by: Barbara A. Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association and Carolyn Herrmann, Deputy General Counsel, Consumer Healthcare Products Association

2:00 – 2:15 pm | Networking Break

2:15 – 3:15 pm | 2017-18 Federal Update and Forecast

  • Presented by: Michael P. Strazzella, Chair, Federal Government Relations, Buchanan Ingersoll & Rooney and William Garvin, Shareholder, FDA/Biotechnology Practice, Buchanan Ingersoll & Rooney

3:15 – 3:30 pm | Networking Break

3:30 – 4:30 pm | DSCSA Regulations: What Spec Pharma Needs to Know

  • Presented by: Barbara Binzak Blumenfeld, Shareholder, FDA/Biotechnology Practice, Buchanan Ingersoll & Rooney

5:00 p.m. Dinner at Kellari Taverna. [Directly next door to Buchanan office. Dinner is included in your registration fee.]

Thursday, August 24

8:00 | Breakfast in Potomac Room

8:30 – 9:30 am | State Licenses and Registrations

  • Presented by: Edward Rickert, Partner, Quarles & Brady LLP
9:30 - 9:45 am | Networking Break

9:45 - 10:45 am | Pharmacovigilance Agreements
  • Presented by: Chris J. Holmes, Director of Healthcare and Life Sciences-Disputes, Regulatory, Compliance & Investigations, Navigant Consulting
10:45 - 11:00 am | Networking Break

11:00 am - 12:00 pm | Medical Foods, Dietary Supplements, etc., and their Proposed Reclassification by First Data Bank
  • Presented by: William A. Garvin, Shareholder, FDA/Biotechnology Practice and Lloyd Smith, Shareholder, IP Practice, Buchanan Ingersoll & Rooney

After the workshop you are encouraged to visit your Congressmen/women



Cost: $295 which includes dinner Wednesday night
 

*Deadline to register is August 19, 2017.

 
Hotel accommodations: