7TH ANNUAL PHARMACEUTICAL REGULATORY OPERATIONS AND SUBMISSIONS PUBLISHING STRATEGIES CONFERENCE

JUNE 14-15, 2018 | BOSTON, MA

HYATT REGENCY BOSTON

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DAY ONE | THURSDAY, JUNE 14

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 PANEL DISCUSSION: OPTIMIZING SUBMISSION TIMELINE AND PROJECT MANAGEMENT STRATEGIES

  • Methods to decrease deadline strain on downstream publishing tasks
  • Change control: Tracking dossier revisions and edits through product lifecycle
  • Resource and manpower management best practices
  • Publishing readiness: Continuous dossier component quality reviews

Milagros Vitor-Butzen, TAKEDA VACCINES

Avrind Ala, Associate Director, Regulatory Operations, EMD SERONO

Karin Zeh, Head Program Management & Regulatory Operations, ZAFGEN

 

9:45 DECODING THE UPDATES TO MODULE 1 SUBMISSION REQUIREMENTS

  • Risks & benefits to Module 1 grouped submissions
  • Technical rejection of an application in grouped submissions
  • Streamlined processes reducing submission development timelines
  • Advertising & promotional submissions under M1 2253

Sonali Gunawardhana, Of Counsel, WILEY REIN

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 SUCCESSFUL MARKETING SUBMISSION IN ACCORDANCE WITH NEW MODULE 1 GUIDELINES
Regulatory operation teams are currently navigating the transition towards submitting ad/promo materials in eCTD format, to ensure compliance with the new US M1 specifications (DTD v3.3). Under the updated guidance for M1, once an application converts to the new specifications, it is unable to transfer to an older version; therefore, the development of a streamlined and fluid process for submitting marketing material is critical for organizations to ensure submission and material approvals remain compliant with this update guidance. The following case study presentation will highlight the steps taken by one organization to overcome the hurdles of transitioning to this new submission model.

Fran Quinn, Team Lead – US Publishing, PFIZER

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:00 SMALL GROUP DISCUSSIONS: FORECASTING THE IMPACT OF RWE INCLUSION IN PRODUCT SUBMISSIONS
Recent regulatory debate has led to an increased focus on the inclusion of real world evidence (RWE) in regulatory considerations and approvals, which would allow for more real life product data for health authorities to review and also compare to clinical evidence. The likelihood of regulatory reviewers’ increased focus and interest in real world data for product approval decision-making entails a plethora of challenges for regulatory operations teams, ranging from understanding the weight of RWE versus traditional trial data, patient population information inclusion strategies as well as data highlighting within the product dossier. In the effort of clarifying the future of RWE consideration parameters in approval decisions, and comparing potential impact scenarios, perspectives from regulatory operations executives will be confronted and debated to efficiently forecast impending changes.

 

1:45 CURRENT GUIDELINES FOR IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

  • Timeline considerations for IDMP implementation
  • Decoding data requirements according to ISO standards
    • ISO 11615 – Medicinal Product (MPID)
    • ISO 11616 – Pharmaceutical Product (PHPID)
    • ISO 11238 – Substance, Specified Substance
    • ISO 11239 – Dose Form, Route of Admin, Packaging
    • ISO 11240 – Units of Measurement
  • Global considerations when implementing IDMP
  • Incorporation of IDMP information into product dossier

Vahe Ghahraman, Sr. Director, Global Regulatory Operations, ALEXION PHARMACEUTICALS

 

2:30 COFFEE & NETWORKING BREAK

 

3:00 STREAMLINING SUBMISSION PROCESS WITH THOROUGH EMPLOYMENT OF RIM SYSTEMS
Regulatory information management (RIM) systems when leveraged and utilized strategically offer manufacturers the opportunity to streamline and unify previously unconnected regulatory related content; increasing the ease along with speed of data compilation for dossier creation. Capturing, management and dissemination of all clinical and regulatory-focused documents through a compliant RIM system can greatly streamline product’s internal approval processes. While the employment of RIM software and storage capabilities provides a variety of operational efficiencies, regulatory executives must remain vigilant of compliance and quality considerations when integrating RIMs into submission publishing.

  • Value story: Cost benefits of RIM implementation
  • RIMs role in regulatory authority correspondence
  • Impact on submission planning management

Vincent Peszek, Director International Business Manager, MERCK

 

4:00 ENHANCING SUBMISSION DOSSIER QUALITY THROUGH STRINGENT REVIEW PROCESSES

  • Considerations in reviewing data integrity
    • Record accuracy
    • Source data availability
  • Strategies to minimize unknown formatting errors
  • Decreasing risk during dossier development
    • Version control
    • Document and data handoffs
  • Adopting internal business drivers to support dossier quality

Karin Zeh, Head Program Management and Regulatory Operations, Zafgen

 

4:45 PARADIGM SHIFT IN STRUCTURED DATA: BENEFITS FROM INCREASED STRUCTURED DATA SUBMISSIONS TO HEALTH AUTHORITIES?

  • When Europe shifts from xEVMPD to IDMP master data with SPOR, structured data submission will shift from a post-hoc administrative activity to an in-process regulatory activity
  • What can we learn from this, and how can we apply it to our own RIM processes?
  • Changing how we look at structured data can bring significant benefits to industry and to our patients

Kelly Hnat, Principal, K2 CONSULTING/ Formerly Senior Director, Regulatory Information Management, TEVA PHARMACEUTICALS

 

5:30  CLOSING REMARKS & DAY ONE CONCLUSION

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