7TH ANNUAL PHARMACEUTICAL REGULATORY OPERATIONS AND SUBMISSIONS PUBLISHING STRATEGIES CONFERENCE

JUNE 14-15, 2018 | BOSTON, MA

HYATT REGENCY BOSTON

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DAY TWO | FRIDAY, JUNE 15

8:30 REGISTRATION & WELCOME COFFEE

8:55 OPENING REMARKS

9:00 CDISC REGULATORY GUIDELINES: IMPACT ON REGULATORY SUBMISSION DOSSIER CREATION

  • Review data expectations
    • CDASH
    • ISDTM
    • IADaM
  • Functionality of executable files & XML backbones
  • Submission team involvement in data set quality review
  • Impact of data sets located in M5

Olga Alfieri, Director, Global Submissions Management, EISAI PHARMACEUTICALS

 

10:00 COFFEE & NETWORKING BREAK

 

10:30 WORKSHOP: REDUCING THE RISK OF REGULATORY REJECTIONS DUE TO TECHNICAL DEFICIENCIES
Product submission rejection from a regulatory reviewer, due to lack of navigability, file format incompatibility or numerous other technical deficiency possibilities is a highly undesirable scenario for manufacturers. In an interactive workshop setting, the facilitator will provide small groups with specific scenarios addressing dossier technical deficiencies faced by pharmaceutical organizations during the submission process, and collaboratively discuss potential mitigation tactics. Groups will share experiences and learn how industry colleagues have managed similar situations in the past, allowing for a maximized number of valuable information to take-away.

Luke Everhart, Senior Specialist, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

 

11:15 SMALL GROUPS: TIPS, HINTS AND BEST PRACTICES FOR REGULATORY PUBLISHING SOFTWARE AND TECHNOLOGY
In the process of developing, submitting and maintaining product submission dossiers, regulatory operations teams employ and work with a variety of different publishing software, document and regulatory intelligence management systems as well as cloud based servers. As with any technology or software, there is learning curve to uncover streamlined processes and ease development of dossiers that can only be garnered through continued use of these products. These facilitated discussions will provide participants with an opportunity to delve into sharing best practices and lessons learned for many technologies and software utilized by executives for dossier management and publishing.

  • Cloud based sharing & storage
  • Regulatory publishing software
  • Microsoft Office tools
  • Document management tools
  • AI and digital tools

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:00 CREATION OF REUSABLE SUBMISSION DOCUMENTS GLOBAL DOSSIER PUBLISHING
The drive to increase global availability of pharmaceutical and biotechnology products requires the development of a multitude of regulatory submission dossiers for review by regional health authorities. While harmonization is a driving factor amongst many regulatory authorities and manufacturers, there are still many inconsistencies regarding data requirements and formatting guidelines across the regional regulatory landscape. As regulatory operations teams work to create and compile extensive amounts of clinical data for dossiers, a primary goal for publishing teams is to reduce document re-work by preparing modules that can easily be utilized within multiple product dossiers.

  • Repurposing common content
  • Authoring strategies to reduce re-writes
  • Global review strategies for dossier documents
  • Reuse of data across sections and modules

1:00 INOVIO CASE STUDY
Luke Everhart,Senior Specialist, Regulatory Operations & Submissions, INOVIO PHARMACEUTICALS

1:25 BLUEBIRD BIO CASE STUDY
Rachel G. Carle, Sr Director, Regulatory Operations & Compliance, BLUEBIRD BIO

1:50 Q&A WITH CASE STUDY PRESENTERS

 

2:00 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.

 

2:45 DOSSIER MANAGEMENT SOURCING STRATEGY AND FOSTERING COLLABORATIVE RELATIONSHIP WITH EXTERNAL PARTNERS

  • Sourcing Strategy in alignment with business drivers
  • Identification of core vs non-core activities in Dossier Management and Target Operating Model
  • Strategic partnership with external partners
  • Continuous improvement through effective governance

Milan Shah, Head, Document Publishing Solutions, Regulatory Submission Management & Operations
JOHNSON & JOHNSON

 

3:30 CLOSING REMARKS & CONFERENCE CONCLUSION

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