On 22 July 2019 FDA issued its much-anticipated Final Guidance on Postmarketing Safety Reporting for Combination Products. While the final guidance provides several clarifications from the draft guidance and final rule, certain challenges remain with respect to effective implementation of its requirements. Offered in collaboration with the Combination Products Coalition (CPC), this program provides the unique opportunity to work with representatives from FDA, as well as Industry veterans, to examine the Final Guidance and find out what your company needs to do to be in compliance by the rule’s effective date of 31 July 2020.
During the workshop you will hear directly from FDA experts regarding key takeaways from the Final Guidance, the Agency’s interpretation of the applicable requirements, and other important topics to anyone who works in this space. This is your chance to submit questions that you have to work through any questions you might have about the Final Guidance, and also let FDA know where additional gaps may exist.
Working in small groups facilitated by Industry experts from the CPC, you will use a case study approach to explore concepts from the Final Guidance, identify best practices for effective implementation, and note areas where additional clarity from FDA would be beneficial. The findings from these case study sessions will be presented to the broader audience and FDA and will be topics for discussion in a closing roundtable session. Don’t miss this crucial opportunity to provide input on these pivotal issues that could affect you for years to come.
Program Date: 15 November 2019
Meeting Location:
Regulatory Affairs Professionals Society - HQ Office
5635 Fishers Lane, Terrace Level
Rockville, MD 20852
Registration Closes: 8 November 2019
Refund Deadline: 16 October
RAC Credits: 6 RAC recertification credits upon completion of the program
Will this meeting be recorded? No
Proof of Attendance: An electronic letter of attendance will be sent upon request.
Registration Fees
Registration to 17 October
RAPS Members: $150
Nonmembers: $150
Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.
Objectives
- Understand key takeaways from the Final Rule and best practices for risk management.
- Assess challenges to effective implementation and address remaining gaps.
- Discuss potential solutions and recommendations that will require FDA and industry collaboration.
Who Should Attend
This program is intended for individuals working at all professional levels in the drug, device, biologic, and combination product space. Anyone involved in post-market safety, pharmacovigilance, medical device reporting, and all other quality, regulatory, or compliance issues will greatly benefit from attending.
Agenda
- Examining the Final Rule and Draft Guidance (Panel Discussion)
- Understanding the Draft Guidance-An Industry Perspective
- Case Study, Session 1
- Case Study, Session 2
- Review of Case Study Findings
NOTE: Program content may vary
Faculty
- Khaudeja Bano, MD – head of medical affairs, postmarketing safety working group, chair, Abbott Diagnostics
- Melissa Burns, program coordinator, office of combination products, US FDA
- Isaac Chang – supervisory biomedical engineer, office of medical products and tobacco, US FDA
- John (Barr) Weiner – general attorney, office of combination products, US FDA
- Maureen Melvin – supervisory health science, office of surveillance and epidemiology, US FDA
- Craig Zimmerman – center for biologics evaluation and research, US FDA
- Suranjan De – deputy director, center for drugs evaluation and research, US FDA
IMPORTANT: Attendees must bring their own laptops. RAPS does not provide equipment for attendees.
Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.
Registration Form
If it is your preference, please use the registration form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Questions?
Call RAPS Solution Center at +301.770.2920, ext. 200.
Refund Deadline: 16 October
Other Information
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Program Contact
Nichelle Sankey
nsankey@raps.org
+301 770 2920, ext. 291
Parking
Paid parking is available in the parking ramp directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention).
Area Airports
Ronald Reagan Washington National Airport (24 miles)
Washington Dulles International Airport (36 miles)
Baltimore-Washington International Airport (37 miles)
Area Hotels
Even Hotel Rockville (Walking Distance)
1775 Rockville Pike
Rockville, MD 20852
Reservations: +1 877 834 3613
Hilton Washington DC/Rockville Hotel (Walking Distance)
1750 Rockville Pike
Rockville, MD 20852
Reservations: +1 301 468 1100
Bethesda North Marriott Hotel
701 Marinelli Road
Bethesda, MD 20852
Reservations: +1 301 822 9200
Bethesda Marriott Suites
6711 Democracy Boulevard
Bethesda, MD 20817
Reservations: +1 800 228 9290
Washington Metro Access
The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station.
Cancellation
All cancellation requests must be submitted to raps@raps.org by 16 October. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed.
Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 1 November.
If you have questions or concerns, please contact RAPS customer service at +301 770 2920, ext. 200, or via email at raps@raps.org.
NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.