2nd Annual Combination Product Regulations Conference

March 4-5, 2020 | Arlington, VA

2nd Annual Combination Product Regulations Conference
March 4-5, 2020 | Arlington, VA

Request Invite

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

“I should be thanking you for this great opportunity to participate in the Q1 conference! The presentation gave useful information to the industry, and this also provided a good occasion for networking.”

Certification Project Manager
G-Med North America

“Because of the smaller venue I felt there was more engagement among the attendees. There was a level of openness in the panel discussions that you rarely see at conferences.”

Associate Director, Device Quality
Merck

“You arranged a great cross-section of topics.”

VP Product Labeling & User Documentation
Siemens Healthineers

“The format of the conference was built in a way to allow discussion through panels but also the transmission of information during sessions – this was a success as there were many questions and discussions going on during those two days.”

Certification Project Manager
G-MED North America

“The quality of the speakers and presentations exceeded my expectations. I enjoyed the conference very much.”

Vice President, Regulatory Affairs & Quality Assurance
Aesculap

About the Conference:

Regulatory affairs teams for combination products must collaborate with the FDA in the early development stages to determine primary mode of action and Agency jurisdiction, ultimately affecting the regulatory strategy organizations employ for a timely and streamlined approval process. In addition to communicating with US regulatory bodies, executives also maintain constant awareness of international requirements affecting combination products, such as EU MDR and changing expectations in emerging markets, including China, Southeast Asia, and Latin America. As organizations determine strategies and markets to enter, combination products must also remain compliant with post market reporting requirements and practices.

Core Topics to be Addressed:

  • Establishing primary mode of action & appropriate FDA jurisdiction
  • Changes in regulatory requirements for US & international markets
  • Collaboration on device & drug constituents for submission process
  • Demonstrating safe use through human factors & usability testing
  • Compliance with updated FDA post market reporting requirements

Program Highlights:

  • Diverse perspectives from device & pharmaceutical companies
  • Small groups to discuss top challenges & brainstorm approaches
  • Focus on practical solutions to speed time to approval & market

Core Topics to be Addressed:

  • Establishing primary mode of action & appropriate FDA jurisdiction
  • Changes in regulatory requirements for US & international markets
  • Collaboration on device & drug constituents for submission process
  • Demonstrating safe use through human factors & usability testing
  • Compliance with updated FDA post market reporting requirements

Request Invite

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

Audience

75 Attendees

All attendees come directly from life science companies

Distinguished Presenters

Speaker recruitment in progress

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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