About

Securing Timely and Positive CMC Regulatory Approvals through a Comprehensive Understanding of ICH Standard Expectations and Decoding the Global Regulatory Landscape
2
Days
11
Speakers
14
Sessions
5. - 6. June, 2024 | Chicago, IL, USA

10th Annual Global Regulatory Affairs CMC Conference

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Speakers

Chong-Hui Gu
Chong-Hui Gu
Head of CMC and QA FOGHORN THERAPEUTICS
Yemin Xu
Yemin Xu
Director, CMC Regulatory Affairs PROKIDNEY
Sai Bhamidipati
Sai Bhamidipati
Regulatory Affairs Associate Director VERTEX PHARMACEUTICALS
Karen Spratt
Karen Spratt
Associate Director, CMC Regulatory Affairs JOHNSON & JOHNSON
Gopi Vudathala
Gopi Vudathala
Head, Global Regulatory Affairs CMC INCYTE CORPORATION
Christina Markus
Christina Markus
Partner KING AND SPALDING
Yolanda Caringal
Yolanda Caringal
Director BRISTOL MYERS SQUIBB
Angela Turner
Angela Turner
Senior Director, Regulatory Affairs ALMATICA PHARMA
Yanhuai Ding
Yanhuai Ding
Senior Director, CMC EVOVLEIMMUNE THERAPEUTICS
John Serio
John Serio
Partner WITHERS BERGMAN LLP
Ramiro Barriga
Ramiro Barriga
Product Expert Medical Devices TUV SUD

Program

9:30 AM - 9:55 AM

ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME

Main Stage

9:55 AM - 10:00 AM

Chairperson's Opening Remarks

Main Stage

10:00 AM - 10:45 AM

KEYNOTE PANEL: INDUSTRY INFLUENCE IMPACTING THE EVER-CHANGING CMC ROLE

Main Stage

10:45 AM - 11:30 AM

UPCOMING & PROPOSED REGULATIONS OF SPECIFIED PRODUCT MATERIALS

Main Stage

Angela Turner

11:30 AM - 12:00 PM

VIRTUAL NETWORKING & COFFEE BREAK

Main Stage

12:00 PM - 12:30 PM

NOTIFIED BODY FIRESIDE CHAT: REGULATORY CONSIDERATIONS TO ENSURE CMC COMPLIANCE

Main Stage

Ramiro Barriga

12:30 PM - 1:15 PM

CMC FACTORS & OPERATIONAL PROCEDURES FOR 505(B)(2) APPLICATIONS

Main Stage

Christina Markus

Contact information

Event date:
5. June - 6. June, 2024
Event location:
Chicago, IL, USA
Organizer:
[email protected]
Contact organizer

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