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Securing Timely and Positive CMC Regulatory Approvals through a Comprehensive Understanding of ICH Standard Expectations and Decoding the Global Regulatory Landscape

2

Días

11

Ponentes

14

Sesiones

5. - 6. junio, 2024 | Chicago, IL, USA

10th Annual Global Regulatory Affairs CMC Conference

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Ponentes

Chong-Hui Gu

Head of CMC and QA FOGHORN THERAPEUTICS

Yemin Xu

Director, CMC Regulatory Affairs PROKIDNEY

Sai Bhamidipati

Regulatory Affairs Associate Director VERTEX PHARMACEUTICALS

Karen Spratt

Associate Director, CMC Regulatory Affairs JOHNSON & JOHNSON

Gopi Vudathala

Head, Global Regulatory Affairs CMC INCYTE CORPORATION

Christina Markus

Partner KING AND SPALDING

Yolanda Caringal

Director BRISTOL MYERS SQUIBB

Angela Turner

Senior Director, Regulatory Affairs ALMATICA PHARMA

Yanhuai Ding

Senior Director, CMC EVOVLEIMMUNE THERAPEUTICS

John Serio

Partner WITHERS BERGMAN LLP

Ramiro Barriga

Product Expert Medical Devices TUV SUD

Agenda

9:30 a. m. - 9:55 a. m.

ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME

Main Stage

9:55 a. m. - 10:00 a. m.

Chairperson's Opening Remarks

Main Stage

10:00 a. m. - 10:45 a. m.

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

Main Stage

10:45 a. m. - 11:30 a. m.

UPCOMING & PROPOSED REGULATIONS OF SPECIFIED PRODUCT MATERIALS

Main Stage

Angela Turner

11:30 a. m. - 12:00 p. m.

VIRTUAL NETWORKING & COFFEE BREAK

Main Stage

12:00 p. m. - 12:30 p. m.

NOTIFIED BODY FIRESIDE CHAT: REGULATORY CONSIDERATIONS TO ENSURE CMC COMPLIANCE

Main Stage

Ramiro Barriga

12:30 p. m. - 1:15 p. m.

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

Main Stage

Christina Markus

Menú personalizado

Información de contacto

Fecha del evento:

5. junio - 6. junio, 2024

Ubicación del evento:

Chicago, IL, USA

Organizador:

[email protected]

Contactar organizador

La mejor experiencia de eventos con aplicación

10th Annual Global Regulatory Affairs CMC Conference

Chong-Hui Gu

Yemin Xu

Sai Bhamidipati

Karen Spratt

Gopi Vudathala

Christina Markus

Yolanda Caringal

Angela Turner

Yanhuai Ding

John Serio

Ramiro Barriga

Agenda

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ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME

Chairperson's Opening Remarks

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

UPCOMING & PROPOSED REGULATIONS OF SPECIFIED PRODUCT MATERIALS

VIRTUAL NETWORKING & COFFEE BREAK

NOTIFIED BODY FIRESIDE CHAT: REGULATORY CONSIDERATIONS TO ENSURE CMC COMPLIANCE

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

Fecha del evento:

Ubicación del evento:

Organizador:

La mejor experiencia de eventos con aplicación