Track 5: Regulatory

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

• Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing 
• Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China 
• Preparing for a US FDA Advisory Committee Meeting 
• Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

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Monday, June 19

The Evolution of Evidence Generation: Real World Evidence and the Next Generation of Decision-Making
• Update From the CFDA
• Brexit: Where Are We Now?
• PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI
• PMDA Town Hall

Tuesday, June 20

• Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?
• What’s New in Devices: European Medical Device Regulations and MDUFA IV
• The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry
• Recent Trends in Asian Regulations for Drug Development: What is Coming Next?
• Regulatory Challenges with Next Generation Sequencing
• The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence 
• Update From Health Canada
• International Collaboration in Times of Public Health Crisis
• Update from CBER: Advancing the Development of Complex Biologic Products
• ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act

Wednesday, June 21

International Regulatory Convergence
• Evolution of Novel Registration Endpoints as Diseases Become Chronic
• Expanded Access and Compassionate Use
• Lessons Learned from the Sarepta Exondys 51 Approval
• Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval
• Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies
• Global Perspective on ICH: Part 1 and Part 2
• The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator
• FDA–Health Canada Regulatory Cooperation Council Town Hall
• Understanding the New Common Rule and its Impact to Industry

Thursday, June 22

FDA Forum
EMA/FDA Question Time

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:

• Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
• Regulatory Affairs: The IND, NDA, and Postmarketing
• New Drug Product Development and Life Cycle Management
• European Regulatory Affairs: Keeping Your Fingers on the Pulse of Marketing Authorizations
• Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets

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