24-28 October 2015, Baltimore
  • No matter how relevant the learning sessions, it’s hard being out of the office and away from home. This year, we’re packing more great content and networking into less time. That means more time for the things that matter most to you. 

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  • Monday, 19 September

    10:00 11:15 am

    Breakthrough Therapy Designation/Accelerated Approval/EMAs PRIME

    The breakthrough therapy designation (BTD) was introduced in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) with an intention to foster innovation for the development of drugs indicated for serious or life threatening diseases or conditions. Ten of the 45 new drugs approved by the FDA in 2015 received BTD. The total number of requests, grant of status, and approvals of BTD increase every year. In early 2016 the European Medicines Agency (EMA) adopted the Priority Medicines (PRIME) scheme. PRIME is being compared to the FDA’s BTD, which speeds up the review process for specific drugs that address serious unmet medical needs. This session will review case studies, breakdown the background of BTD and tackle the pros and cons of EMA PRIME.

    The New EU Clinical Trial Regulation

    Get a breakdown of the new European legislation for clinical trials with pharmaceuticals and find out how the various stakeholders are preparing for the new procedures. The status of implementation of the various requirements into national procedures will be presented. The impact of the upcoming legislative changes from the perspective of US-based organizations will be discussed. Our panel will share their experiences to date and will make practical recommendations on how and when to implement the necessary changes within your organization.

    11:30 am12:30 pm

    Trends and Challenges with Drug Labeling

    Join us for an in-depth look at the history of global labeling alignment over the past several years and the industry trends for the future. We’ll review the regulations and challenges related to maintaining identical safety content between generic and branded labels. Plus, assess the magnitude of inconsistencies of product labeling safety changes in leading products across major markets.

    Delivering the Next Generation of Alzheimer's Treatments: Are We Prepared?

    There are currently 19 Alzheimer’s drugs in Phase III clinical trials, and 17 treatments could launch in the next five years.  Patients and caregivers could witness unprecedented innovation in Alzheimer’s disease treatment development. Many conversations about the regulatory environment focus on the state of play in Alzheimer’s without drawing applicable lessons from other disease areas. Not this conversation. Our panel will not only address issues facing the Alzheimer’s treatment regulatory pathway, but also apply best practices and teachings from disease areas that have already improved their regulatory environments.

    1:303:00 pm

    Integrating Safety, Regulatory and Benefit-Risk Functions: Enhanced Compliance and Efficiency in the Maintenance Phase of the Product Lifecycle
    Implementing Social Media in a Converging Regulatory Environment: Trends Across the Globe

    4:005:30 pm

    Pediatric Studies: Regulatory Challenges and Considerations

    Over the past decade, regulatory legislations for drug development in pediatric patients were passed worldwide, dramatically increasing the number of drugs tested in and labeled for children. This session will speak to various initiatives and updates including the new guidance prepared by the Pediatric Study Plan Working Group. Our panelists will also highlight respective challenges and caveats of the Pediatric Rare Disease Priority Review Voucher (PRV) and the new funding initiative for the EU Horizon 2020.

    Drug Development Trends in Asia Pacific

    With the pharmaceutical industry rapidly adapting their business models in the Asia Pacific region, a growing list of regulatory requirements and expectations are imposing new challenges to regulatory affairs professionals. We’ll face these challenges head on in this session, and provide you guidance on creating a strategy, process and timeline with special considerations and local requirements for drug product registration.

    Global Developments in Cell and Gene Therapy

    Tuesday, 20 September

    8:30–10:00 am

    Update on Rare Disease and Orphan Drug Designations US/EU/Japan

    Orphan drug designations and approvals have shown impressive growth annually over the past 15 years. Join us as we take a look at the newest initiatives to maintain productivity in the US, EU and Japan. Our panelists will also highlight respective challenges and caveats of exclusivities in this growing area of development.

    Aligning Regulatory and Market Access—How to Establish a Drug's Value for Different Stakeholders

    The landscape in drug development and for getting a drug to market is changing. In this session, we will discuss solutions for successful stakeholder interactions during drug development, namely on how value translates from R&D to market and ultimately patients. We’ll critically look at the challenges posed by expedited pathway schemes from the payers’ perspective and how the need for earlier patient access further complicates the drug development considerations. You will also learn how to develop a realistic roadmap for the development of a therapeutically and commercially successful drug.

    10:30 am–12:00 pm

    Regulatory Considerations in Selecting Clinical Endpoints

    1:00–2:30 pm

    Common Rx Drug Advertising/Promotional Deficiencies that Companies Make, but Shouldn't

    3:30–4:45 pm

    Top 10 Lessons Learned When Implementing an eCTD (Including FDA Module 1)

    Biosimilars have made a big impact on drug prescription choice. Biosimilars are officially approved versions of original biologic “innovator” products. Since they are not identical, they are not interchangeable. The EU has been approving them for years, and now the US is addressing requirements. This session will discuss the impact on the marketplace, how the FDA will define interchangibility with reference drugs and outline lessons learned after shortcuts of guidelines led to problems with biosimilar programs.

  • Education By Design

    At the Convergence, attendees can engage in a variety of sessions that cover multiple areas of focus within the regulatory world. The following program tracks are available this year:

    • Bio Icon Biopharmaceuticals

      Key Topics to Include:

      • The New EU Clinical Trial Regulation
      • Breakthrough Therapy Designation/Accelerated Approval
      • Orphan Drugs and Rare Diseases
      • Biosimilars
      • Regulatory Considerations in Selecting Clinical Endpoints
      • Top 10 Lessons Learned When Implementing an eCTD Submissions Program
      • Cell and Gene Therapy/ATMPs
      • Integrating Safety, Regulatory, and Benefit‐Risk Functions: Enhanced Compliance and Efficiency in Maintenance of Products
      • Pediatric Studies: Regulatory Challenges and Considerations
      • Preparing for an Advisory Committee Meeting
      • Common Rx Drug Advertising/Promotional Deficiencies that Companies Make, but Shouldn't
      • Global Labeling Alignment Trends
      • Drug Development Trends in Asia Pacific
      • Implementing Social Media in a Converging Regulatory Environment: Trends Across the Globe
      • Aligning Regulatory Business: Market Access and Planning for Reimbursement in the Biopharmaceutical Sector
      • Transatlantic Trade and Investment Partnership (TTIP)
      • CUBA: “New Horizons” - Regulatory Convergence, Research, Product Development, Market Access
      • How to Overcome Regulatory Hurdles When Entering the Latin American Market: Regulatory Filing, Clinical Trial Opportunities and Strategy Implementation
      • Perspective and Challenges on Latin America Convergence: Moving Forward

    • Health-Related Foods Icon Health-Related Foods

      Key Topics to Include:

      • Ingredients, Review and Safety
      • Dietary Supplements and Claims
      • Current and Recent Changes in Global Medical Food/FSMP
      • The Future of Medical Food/FSMP

    • Legal Icon Legal for Regulatory

      Key Topics to Include:

      • The Physician Payments Sunshine Act
      • HIPAA Compliance and Data Protection
      • Park Doctrine and Foreign Corrupt Practices Act
      • Intellectual Property

    • Medical Devices Icon Medical Devices and In Vitro Diagnostics

      • Software as a Medical Device
      • Mobile Health for Devices and IVDs
      • Innovative Manufacturing Techniques – Custom Devices, Additive Manufacturing and 3D Printing
      • Human Factors and Usability Through the Lifecycle
      • Preclinical Studies for Regulatory Approval
      • Clinical MEDDEV
      • Global Trends in Clinical Evaluation of Medical Devices
      • CDRH Strategic Initiatives/Priorities
      • CDRH Reviewer Panel
      • Medical Devices Single Audit Program (MDSAP)
      • ISO 13485:2016
      • EU MDR and IVDR Regulations
      • Medical Devices in China
      • Japan: Update on MD/IVD Regulations
      • Asia Pacific: Comparison of Key Countries in the Region
      • Global Markets: Focus on Africa/Middle East/Eastern Europe
      • Medical Device Harmonization Initiatives
      • Companion Diagnostics
      • FDA Regulation of LDTs
      • Through the Looking Glass in Next Generation Sequencing Submissions
      • Current State: In Vitro Diagnostic Device Studies Using Leftover Human Specimens
      • Global Requirements for Labeling
      • Unique Device Identifiers
      • Aligning Regulatory Business: Market Access and Planning for Reimbursement in the Medical Device Sector
      • Regulatory Business Strategy for Product Development
      • Update on Changes in the Orthopedic Industry

    • Multiple Icon Multiple Themes

    • Regulatory Business Icon Regulatory Business

      Key Topics to Include:

      • Critical Thinking Skills
      • Handling Regulatory Challenges: How to Respond With Grace under Pressure
      • Regulatory Audits for Mergers & Acquisitions: Avoiding Common Mistakes
      • Communication and Negotiation
      • Dangerous Documents: Avoiding Land Mines in Your Emails and Documents
      • A Day in the Life of an FDA Regulatory Project Manager (RPM): Beyond the Guidance
      • Regulatory Decision Making
      • Real World Evidence
      • Regulatory Intelligence

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