Combination Products Regulation Conference

February 28 – March 1, 2019 | Arlington, VA
Hilton Crystal City at Washington Reagan National Airport
Download Agenda

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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

As medical products have increased in sophistication, the combination product market has experienced expansive growth, particularly in the area of implantable devices with drug-eluting components, drug delivery and monitoring systems, as well as a burgeoning home-care market, all of which face unique regulatory challenges in ensuring the safety and efficacy of multiple product mechanisms. From early-stage product development and clinical research strategies which will ultimately support a swift and positive regulatory approval to maneuvering in evolving regulatory markets such as Europe and Asia, executives specializing in combination product regulations face unique hurdles in bringing products to market.

Topics Being Addressed Include:

  • Study Design that Bridge Drug-Device Evidence Needs
  • Appealing FDA Decisions on Primary Mode of Action
  • Clarification on Device Referencing Drugs Pathway
  • Global Considerations: EU MDR, Asian Country Updates
  • ISO 10993:1 Biocompatibility & Material Assessment
  • Future of Combination Products: Software Integration

Program Highlights:

  • Equal Mix of Pharmaceutical + Medical Device Speakers
  • In-depth Presentations Diving into Regulatory Nuances
  • Multiple Breakout Sessions for Small Group Interaction
  • Legal Perspectives On-Hand to Interpret Guidelines

Audience

75 Attendees

All attendees come directly from life science companies

Distinguished Presenters

20 Speakers

with an average of 15 years experience

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

CONTACT US
Q1 Productions
500 N. Dearborn Suite 500
Chicago, IL 60654
T: 312.822.8100
F: 312.873.3969
marketing@q1productions.com

 

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