Combination Products June 8, 2017
Falls Church, VA (PRWEB) May 05, 2017
Combination Products Regulation, Policy & Best Practices:
It’s a Whole New Ballgame — Are You All In?
**Presented by FDAnews**
June 8, 2017, Washington, DC
http://www.fdanews.com/comboregs
Combination products are streaming to market just as Washington makes the game tougher to play. Manufacturers need to be on top of:
- The role of the Combination Products Policy Council, pre-RFDs, the pilot for improving inter-center review, and the expanded role of the Office of Combination Products
- Successful strategies for obtaining jurisdictional determination, assuring certainty with submission requirements, and overcoming barriers to combination product approval
It’s a lot to know and a lot to comply with. Before leaping forward with combination products, manufacturers need to get up to speed.
Plan now to attend FDAnews’s first-ever all-day conference on combination products featuring 17 experts from every background — drugs, devices, biologics, generics, regulatory, legal, consulting and more. Attendees will be able to:
- Understand postmarket safety reporting and current good manufacturing practices requirements for combination product and constituent part sponsors
- Comply with the unique considerations for advertising and marketing combination products. Know the important findings for a human factors study of a generic combination product with device delivery constituent part
- Implement best practices for submitting combination products directly to CDRH and implications of the Cures Act on these submissions
Attendees will come away with a regulatory survival strategies including safety reporting and cGMP, advertising and marketing in the combination-products era, how to submit combination products directly to the CDRH and much more.
Attend this all-day Washington event in person if possible — the networking opportunities alone justify the time and expense. If not the entire conference is being livestreamed at registration savings of $50.
The combination-products train is leaving the station. Get on board with this full-day working session featuring 17 speakers including top regulatory lawyers, industry execs and knowledgeable consultants, and covering all the bases. Time is short though.
Who Will Benefit:
- Combination products developers
- Compliance specialists
- Regulatory affairs professionals
- Quality specialists
- Attorneys
- Consultants
Conference Details:
Combination Products Regulation, Policy & Best Practices:
It’s a Whole New Ballgame — Are You All In?
**Presented by FDAnews**
June 8, 2017, Washington, DC
http://www.fdanews.com/comboregs
Tuition:
In-Person Briefing: $397
Livestreaming: $347
Easy Ways to Register:
Online: http://www.fdanews.com/comboregs
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
