Global Regulatory Perspectives Workshop
[vc_row][vc_column][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column width=”1/2″][vc_column_text]Pre-Conference Day
Wednesday May 27, 2020
08:00 – 16:45
Palais des Congrès de Paris
Room: TBD[/vc_column_text][vc_empty_space][/vc_column][vc_column width=”1/2″][vc_column_text]
[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space][vc_column_text]Access for Pre-Conference Day tracks are valid with a Pre-Conference or Conference Bundle registration.[/vc_column_text][vc_empty_space][vc_column_text]
[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space][vc_column_text]The ISCT Global Regulatory Perspectives (GRP) workshop represents the diverse activities and partnerships between international regulatory bodies, industry, clinicians and academia.
Confirmed regulators include: FDA, EMA, PEI, PMDA and Swissmedic.
The highly interactive program will feature presentations and case studies on sterility controls, post manufacturing processing, combination products, and considerations following rapid approvals.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]
Supporting Organization
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Program
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Regulatory Roundup
Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, United States
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Session 1: Sterility Controls – Past, Present, Future
Followed by Case Study
Moderator
Dominic Wall, PhD FFSc (RCPA), Cell Therapies Pty Ltd, Peter MacCallum Cancer Centre, Australia[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]
Session 2: Issues Related to Product Administration at the Clinical Site
Followed by Case Study
Moderator
Christopher Bravery, PhD, Consulting on Advanced Biologicals United Kingdom
Regulator
Martina Schüssler-Lenz, MD, CAT Chair, EMA, United Kingdom
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Session III: Combination Products (Biologics/Devices)
Followed by Case Study
Moderator
Karen Nichols, Esq., Magenta Therapeutics, United States
Regulators
Melanie Eacho, PhD, Chief, Cell Therapy Branch, Division of Cellular and Gene Therapies, OTAT, FDA/CBER, United States
Ralf Sanzenbacher, PhD, Deputy Head of Section Somatic Cell Therapeutics and TE, PEI, Germany
Misaki Naota, Reviewer, Office of Cellular and Tissue-based Products, PMDA, Japan
Industry
David DiGiusto, PhD, Chief Technical Officer, Semma Therapeutics, United States[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”15″][vc_column_text]
Session 4: Rapid Approvals
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Organizing Committee
[/vc_column_text][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column width=”1/2″][vc_column_text]Karen Nichols, Esq.
Co-Chair
Magenta Therapeutics
United States
Yong Fan, MD
A2Z Reg Solutions
United States
Christopher Bravery, PhD
Consulting on Advanced Biologicals
United Kingdom
Scott Burger, MD
Advanced Cell & Gene Therapy
United States[/vc_column_text][/vc_column][vc_column width=”1/2″][vc_column_text]Dominic Wall, PhD, FFSc(RCPA)
Co-Chair
Cell Therapies Pty Ltd, Peter MacCallum Cancer Centre
Australia
Srinivasan Kellathur, PhD
Advanced Therapy Products Unit, Health Sciences Authority
Singapore
Janet Macpherson, PhD
GE Life Sciences
Australia[/vc_column_text][/vc_column][/vc_row]