The Essentials: US Regulatory Affairs Workshop
Agenda
| Saturday, 22 October 2011 |
| 8:30 am |
Registration and Continental Breakfast |
|
9:00 am
|
Welcome and Day I—Medical Devices and IVDs
Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting Inc.
|
|
9:15 am
|
Overview of Medical Devices and IVDs
- 510(k)
- PMA perspectives
- IDE & HDE
- Clinical
- QSR/GMP
- Submission Supplements
- Postmarket
David E. Chadwick, PhD, RAC, director, regulatory affairs/regulatory science, Cook, Inc.
Heather Rosecrans, senior advisor, regulatory affairs, Greenleaf Health LLC
|
| 10:30 am |
Refreshment Break |
|
11:00 am
|
Medical Devices and IVD’s (continued)
|
| 12:30 pm |
Lunch |
|
1:30 pm
|
Advertising, Promotion and Labeling
Amy Fairfield, principal consultant, global regulatory affairs, Eli Lilly and Company
|
|
2:15 pm
|
Risk Management
Hal Yeager, global product safety, Eli Lilly and Company and chairman, ISO Technical Committee 84
|
| 3:00 pm |
Refreshment Break |
|
3:30 pm
|
Compliance and Enforcement
Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting Inc.
|
| 5:00 pm |
Wrap-up and Adjourn |
| Sunday, 23 October 2011 |
| 7:30 am |
Registration and Continental Breakfast |
|
8:30 am
|
Welcome to Day 2— Drugs and Biologics
Alan Minsk, JD, partner and chair, food and drug practice team, Arnall Golden Gregory, LLP
|
|
8:45 am
|
Overview of Drugs and Biologics
- NDA /ANDA
- IND
- P&P
- Clinical
- GMP
- Supplements
- Adverse Event reporting
Thomas Class, group director regulatory affairs, Shire Human Genetic Therapies
Gretchen Bowker, chief operating officer, Pearl Pathways
|
| 10:00 am |
Refreshment Break |
|
10:30 am
|
Drugs & Biologics (continued)
|
| 12:00 pm |
Lunch |
|
1:00 pm
|
Advertising, Promotion and Labeling
Alan Minsk, JD, partner and chair, food and drug practice team, Arnall Golden Gregory, LLP
|
| 2:30 pm |
Refreshment Break |
|
3:00 pm
|
Risk Management
Alan Minsk, JD, partner and chair, food and drug practice team, Arnall Golden Gregory, LLP
Jean Wright, PhD, global regulatory coordinator, REMS lead, US regulatory affairs, Eli Lilly and Company
|
|
3:45 pm
|
Compliance and Enforcement
Nancy Singer, JD, RAC, founder, Compliance-Alliance LLC
|
| 5:00 pm |
Wrap-up and Adjourn |
|
|