Understanding the Draft Guidance on Postmarketing Safety Reporting for Combination Products – An Interactive Analysis with FDA and Industry

RAC Credits
Thursday, 31 May 2018 (9:00 AM) - Thursday, 31 May 2018 (3:00 PM) (Eastern Time (US & Canada))
601 13th St NW
Washington, DistrictofColumbia, USA, 20005-3807

On 20 December 2016, FDA issued its much-anticipated Final Rule on Postmarketing Safety Reporting for Combination Products.  While the rule provides several clarifications from the proposed 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 Rule and find out what your company needs to do to be in compliance by the rule’s effective date of 19 July 2018.

What to expect:
You will hear directly from FDA experts regarding key takeaways from the Final Rule, the Agency’s interpretation of the applicable requirements, and other important topics to anyone who works in this space.  This is your chance to work through any questions you might have about the Final Rule, and 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 Rule, 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, including 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:              31 May 2018

Meeting location:      
Amgen Inc.
601 13th Street, NW
Washington, DC 20005

Registration closes:    24 May 2018
Refund deadline:          17 May 2018

RAC credits:                   7 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.

RAPS Member:                  $150
Nonmembers:                   $150

Advance registration is required for this workshop and participants are encouraged to register early. RAPS is unable to process onsite registrations.

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.


  • 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. 


  1. Examining the final rule and draft guidance 
  2. Understanding the draft guidance--an industry perspective 
  3. Case study, session 1
  4. Case study, session 2 
  5. Review of case study findings
  6. Panel discussion

NOTE: Program content may vary. 


  • Khaudeja Bano, MD – senior medical director, postmarket 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 Zinderman – center for biologics evaluation and research, US FDA
  • Steven Silverman - AdvaMed, vice president of technology and regulatory affairs
  • Bradley Merrill Thompson - Epstein Becker Green, Shareholder

Local travel
The Amgen office is approximately a 5 to 7 minute taxi ride from Union Station (Union Station (WAS) Amtrak). The Amgen office is also close to several metro stations (commuter - https://www.wmata.com/) and the station stop Metro Center lets out across the street from the office.

Area hotels
Comfort Inn Downtown DC/Convention Center
1201 13th Street NW
Washington, DC 20005

Washington Plaza Hotel
10 Thomas Circle, NW 
Washington, DC 20005 

Hamilton Hotel
1001 14th Street NW 
Washington, DC 20005 

Kimpton Donovan Hotel
1155 14th Street, NW 
Washington, DC 20005

There are several parking garages that are close to the Amgen office. The building is also served by the Washington Metro Area Transit rail system; the closest station is Metro Center. Delegates may also opt to take a taxi which can be hailed from your hotel, or curbside.

Area airports

  • Ronald Reagan Washington National Airport (10 miles)
  • Washington Dulles International Airport (36 miles)
  • Baltimore-Washington International Airport (37 miles)

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
+301 770 2920, ext. 291