Our agenda is quickly progressing. Don’t miss your chance to be part of the solution at GRx+Biosims 2019. Submissions are unlimited but must be submitted by June 28th. Additionally, to show how much we value your participation, we plan to reward topic suggestions with a special gift. We look forward to seeing your ideas!
Agenda
Learning Tracks
- Quality Applications
- Generic Industry Outlook
- USP in the Supply chain: more than Monographs
- Quality of Generics
- Complex Generics
- Inspections/Compliance
- Combination Products
- Quality Metrics
- Emerging Technology and Continuous Manufacturing
- Data Standards and Quality/Data Integrity
- GDUFA III
- Labeling Workshop
- Commercializing Biosimilars: Discussion with Biosimilars Industry Leaders
- Biosimilars Action Plan Scorecard – Is the FDA Helping Adoption?
- The Importance of Global Regulatory Harmonization for Biosimilars
- Payer Strategies to Drive Biosimilars for Patient Access & Savings
- Federal Focus on Biosimilars: A Lot of Bark and No Bite
- Overcoming Anti-Competitive Tactics to Biosimilars Adoption
- Interchangeable Biologics: Are They Really the Silver Bullet?
- Biosimilars Education Evolution: Changing Perspectives in the Face of Increasing Costs
- Drug Pricing in the States and Update on State Legal Issues
- The Changing Landscape of Patents and Hatch-Waxman
- Biosimilars at the Bar
- Rebalancing U.S. Trade Policy
Conference Program
Day 1
Monday, Nov 4
7:30 a.m.
Registration
7:30 – 8:30 a.m.
Networking Breakfast
8:30 – 9:00 a.m.
Welcome and Introduction
Chester “Chip” Davis, Jr., JD
President & CEO, AAM
9:00 – 10:00 a.m.
General Session
Keynote Address
The Honorable Alex Azar, II (Invited)
Secretary, United States Department of Health and Human Services
Commissioner Keynote Address
Norman (Ned) Sharpless, M.D. (Invited)
Acting Commissioner, FDA
10:00 – 10:30 a.m.
Networking Break
10:30 – 12:00 p.m.
General Session
CMS Keynote Address
Seema Verma (Invited)
Administrator, U.S. Centers for Medicare and Medicaid Services
CDER Keynote Address
Patrizia Cavazzoni, M.D. (Invited)
Deputy Director for Operations, CDER, FDA
OGD Keynote Address
Sally Choe, PhD
Director, Office of Generic Drugs (OGD), CDER, FDA
12:00 – 1:30 p.m.
Networking Luncheon
1:30 – 3:00 p.m.
GRx+Biosims Tracks
3:00 – 3:30 p.m.
Networking Break
3:30 – 4:30 p.m.
GRx+Biosims Tracks
5:00 – 6:30 p.m.
Welcome Reception
Day 2
Tuesday, Nov 5
7:30 – 8:30 a.m.
Networking Breakfast
8:30 – 10:00 a.m.
General Session
ORA Keynote Address
Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
Office of Regulatory Affairs (OFA), CDER, FDA
Biosimilars Keynote Address
Sarah Yim, M.D.
Acting Director for Therapeutic Biologics, Office of New Drugs
Therapeutic Biologics and Biosimilars Team, CDER, FDA
OC Keynote Address
Donald Ashley, JD (Invited)
Director, Office of Compliance, CDER, FDA
10:00 – 10:30 a.m.
Networking Break
10:30 – 12:00 p.m.
General Session
OPQ Keynote Address
Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality (OPQ), CDER, FDA
The USP of Today
Ronald Piervincenzi
Chief Executive Officer, United States Pharmacopeial Convention
12:00 – 1:30 p.m.
Networking Luncheon
1:30 – 3:00 p.m.
GRx+Biosims Tracks
3:00 – 3:30 p.m.
Networking Break
3:30 – 4:30 p.m.
GRx+Biosims Tracks
3:30 – 5:30 p.m.
GRx+Biosims Exposition
4:30 – 6:00 p.m.
Biosimilars Council Meeting
5:30 – 6:30 p.m.
Networking Reception
6:30 – 9:30 p.m.
Dinner & Entertainment
Delicious Dinner + Suspenseful Speakeasy
The Roaring Twenties – it was a time of lively flappers, notorious gangsters and secret speakeasies. Join us as we turn back the clock for an entertaining evening at The Bees Knees, a speakeasy where GRx+Biosims event attendees can get away from the clutches of prohibition for a few hours. It’s all fun and games until a patron runs into foul play. You and your dining companions will be called on to help solve the mystery and identify the culprit… if you can.
Day 3
Wednesday, Nov 6
7:30 – 8:30 a.m.
Networking Breakfast
8:30 – 10:30 a.m.
General Session
Keynote Address
Scott Gottlieb, M.D.
Former Commissioner, FDA
10:30 – 11:00 a.m.
Networking Break
11:00 – 12:30 p.m.
GRx+Biosims Tracks
12:30 – 1:30 p.m.
Networking Luncheon
1:30 – 2:30 p.m.
GRx+Biosims Tracks
2:30 p.m.
GRx+Biosims Concludes
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