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Track 5: Regulatory

DIA 2017: Driving Insights to Action! 

With 24 sessions specific to Regulatory Affairs, this track addresses global laws, regulations, guidelines, and guidances that govern biopharmaceutical and device product development, approval, and life cycle maintenance. Representatives from FDA, EMA, PMDA, MHRA, BfArM, and ICMRA authorities, and other regulatory experts will provide updates, insights, and thoughtful analysis of current issues through interactive forums that allow for open exchange with attendees. Wherever in the world you wish to have your product authorized and marketed, DIA provides access to expert and up-to-date coverage of the regulatory requirements and issues you will need to address.

Highlights in Regulatory

  • PDUFA at 25 – historical look and a view of PDUFA VI
  • Preview of MDUFA IV
  • European Medical Device Regulations
  • BsUFA Reauthorization – impact on the regulator and industry
  • GDUFA Reauthorization
  • Working through divergent regulatory advice in global development programs
  • Simultaneous development of evidence to support both registration and reimbursement – is it achievable?
  • Lessons learned from the Sarepta Exondys 51 (for Duchenne Muscular Dystrophy) approval
  • Harnessing Artificial Intelligence (AI) for actionable regulatory intelligence
  • Trends in Asian regulations for drug development
  • Brexit – impact on the European Regulatory environment
  • CFDA regulatory reform
  • Novel registration endpoints as diseases become chronic
  • Featured Topics in Global Regulatory, Devices and Combination Products, eSubmissions, Public Policy, Patient Centricity, and Career Development

DIA recommends this track and associated sessions to professionals involved in: Regulatory Affairs, Regulatory Operations, Regulatory Information Management, Regulatory Agencies, Government Affairs, Legal Affairs, Compliance, Policy, and Service Providers developing tools and resources for use by sponsors and CROs.

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Sessions in Regulatory

Sunday, June 18 | Short Courses

View All Short Courses

Monday, June 19

Tuesday, June 20

Wednesday, June 21

Thursday, June 22

More on Regulatory: How We Think at DIA

Read the latest insights on Regulatory Science from DIA's digital magazine, the Global Forum, and DIA’s print journal, Therapeutic Innovation and Regulatory Science (TIRS).

Need More on Regulatory Affairs?

DIA’s Learning portfolio offers multiple face-to-face and online opportunities. Our courses provide comprehensive coverage of the full discovery, development, and life cycle management of health care products. DIA’s unique multidisciplinary environment provides learning opportunities not only in participants’ respective fields, but also in related fields—lending new perspectives that help teams collaborate more efficiently and effectively. DIA wants to ensure you’re prepared with the knowledge, solutions, and strategies you need to be successful in in today's complex global regulatory environment.

Upcoming Regulatory Face-to-Face and Online Learning:

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