4th Annual Global Pharmaceutical Regulatory Affairs CMC Conference

October 29-30, 2018 | Philadelphia, PA

Doubletree by Hilton Hotel Philadelphia Airport

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DAY ONE | MONDAY, OCTOBER 29

8:00 REGISTRATION & WELCOME COFFEE

9:00 ICH Q12: IMPLICATIONS OF GUIDELINES ON RISK-BASED CMC OPERATIONS
From 2009 through 2011, ICH guidelines Q8 through Q11 were developed and implemented in order to provide a consistent, science-backed approach to risk-based monitoring of product changes, which culminated in the more recent release of Q12 in November 2017. Designed to provide greater structure for pharmaceutical manufacturers, ICH 12 focuses on regulatory commitments for submission dossiers and provides benchmarks for harmonized operations related to post-approval product changes. It is critical for CMC executives to understand not only the requirements of ICH Q12, but how these standards will be integrated into the current regulatory landscape.

Justin Aldridge, Senior Manager, Regulatory CMC, BIOGEN

 

9:45 SMALL GROUP DISCUSSION: IMPLEMENTATION STRATEGIES OF ICH Q12 PROCESS LED BY LACHMAN CONSULTANTS

MODERATOR: Aloka Srinivasan, Ph.D., Vice President, Head of Regulatory Services, LACHMAN CONSULTANTS

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00-12:30 GLOBAL COMPLIANCE MODULE: DECODING REGIONAL REGULATORY GUIDANCE AND EXPECTATIONS
As pharmaceutical and biotechnology organizations continually look to expand products’ global market availability, the regulatory implications become an on-going challenge for regulatory affairs CMC executives due to the lack of overall harmonization. Initial product submission, data expectations and change control compliance guidelines can vary drastically depending on the region the company is seeking approval; therefore in order to ensure timely approvals and uninterrupted product supply, CMC executives must remain abreast of all regulatory considerations impacting product pipelines. This compliance oriented module will highlight three key regions in the global marketplace allowing for in-depth analysis of country specific regulatory challenges while also offering attendees the opportunity to break into smaller breakouts for further regional educational group sharing.

11:00 REGULATORY EXPECTATIONS OF PMDA

  • Impact of ICH Q12 on current application form system
  • Overcoming tight regulatory response timelines
  • Building document translation into timelines
  • Cultural influences on submission reviews

Eli Zavialov, Director, Regulatory CMC Dossier Development, JANSSEN

 

11:45 GLOBAL SMALL GROUP BREAKOUT DISCUSSIONS
Facilitated discussions will provide participants with an opportunity to delve into unique markets where product approvals and post-market reporting are proving difficult, ensuring knowledge is gathered on regions of most concern.

  • CHINA SMALL GROUP DISCUSSION:
    Catherine Burgess, Vice President, Global Head of CMC Regulatory, Global Regulatory Affairs, TAKEDA
  • EU SMALL GROUP DISCUSSION:
    Art Faulkner, VP, Regulatory CMC, TG THERAPEUTICS
  • RUSSIA SMALL GROUP DISCUSSION:
    Marisa Sepulveda, Associate Director, Global Regulatory Affairs CMC, MORPHOTEK

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

 

2:00 UPSCALING CMC ACTIVITIES FROM US-CENTRIC TO A GLOBALIZED APPROACH
Globalization provides pharmaceutical companies with opportunities in expanding into competitive markets, and CMC executives are analyzing regulatory procedures in new countries and regions to promote organizational growth, while maintaining safety and compliance expectations. Multiple variables affect expansion including current and emerging market needs, regulatory review and approval expectations, organizational structures essential for application of effective resources, and modifications of manufacturing processes to accommodate implementation. Delegates will develop a better understanding of unique CMC submission requirements, necessary agency affiliations, and regulatory requirements exclusive to distinct markets ensuring scale-up activities are undertaken with swift and efficient support from CMC teams.

Lisa Little-Tranter, CMC Regulatory Scientist, ELI LILLY AND COMPANY

 

2:45 PANEL DISCUSSION: CHANGE CONTROL MANAGEMENT AND GLOBAL APPROVAL TRACKING

  • Experiences with leading global authorities’ review timelines
  • Tools and technology for optimized approval tracking
  • Communication with ROW affiliates to decrease review timetables
  • Global regulatory ambiguities regarding change control data

Thomas Dowling, Director, Regulatory/CMC, CELGENE

Marisa Sepulveda, Associate Director, Global Regulatory Affairs CMC, MORPHOTEK

 

3:30 COFFEE AND NETWORKING BREAK

 

4:00 CMC REGULATORY GUIDELINES IMPACTING COMBINATION PRODUCT APPROVAL OPERATIONS
The regulatory standards of combination products in the US and globally often result in confusion during the CMC review cycle due to the complexity of the product and varying expectations regarding required data. Factors that complicate manufacturer’s understanding include the ambiguous regulatory nature of combination products proper documentation needed for various agencies during the review, and evolving regulatory expectations from regulators. CMC executives will gain a better understanding regarding the primary mode of action designation, new regulations and specific agency requirements for submissions, and expectations from device reviewers regarding technical information to include in device and drug submissions.

Art Faulkner, VP, Regulatory CMC, TG THERAPEUTICS

 

4:45 REGULATORY STRATEGY OF AUTOINJECTORS – CHALLENGES, EXPECTATIONS AND REALITY
Prasad Peri, Senior Director, RA CMC, TEVA PHARMACEUTICALS

 

5:30 END OF DAY ONE CONFERENCE

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