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About Event


Intended Audience: Industry professionals from Biostatistics, Statistical programming and data science area.

Event DATE

20th November 2023

Event begins at 09:00 am to 05:30 pm IST

Event LOCATION

Virtual

Speakers

Agenda

# Time Topic Speaker & Organisation
1 09:00-09:10 Introduction of IASCT and overview of the workshop objectives and schedule IASCT Executive Council
09:10-09:15 Introduction of Speakers IASCT Executive Council
2 09:15-10:00 Overview of different regulatory authorities and types of applications
  • FDA
  • EMA
  • PMDA
 Srikar Surapaneni,
Senior Regulatory Professional, Novo Nordisk
Rajesh Krishna,
Senior Regulatory Professional, Novo Nordisk
10:00-10:15 Q&A ALL
3 10:15-11:00 All about HTA Pragnya Mishra,
Manager, Programming, GSK
11:00-11:15 Q&A ALL
11:15-11:25 Short Break
11:25-11:30 Introduction of speaker IASCT Executive Council
4 11:30-12:15 Role of statistician in submission packages Ayan Das Gupta,
Director, Group Head and Global Program Biostatistics Head, Neuroscience, Novartis
12:15-12:30 Q&A IASCT Executive Council
12:30-01:25 Break
01:25-01:30 Introduction of Speakers IASCT Executive Council
5 01:30-02:15 Role of Programmer in submission packages - touchbase on submissions with R Kieran Martin,
R Enablement Lead: PD Data Sciences, Roche
02:15-02:30 Q&A ALL
6 02:30-03:15 Experience sharing on regulatory interactions and negotiation (how to prepare for ADCOM FDA, EMA, PMDA - experience sharing) Hanna Zhelezniak,
Senior Statistical Programmer, ICON
Vijay Vaidya,
Director statistical programming, Astrazeneca
03:15-03:30 Q&A ALL
03:30-03:40 Short Break
03:40-03:45 Introduction of speaker IASCT Executive Council
7 03:45-04:30 Workshop on Regulatory Q&A – Discussing different scenarios and solutions and responses from regulatory Vijay Vaidya,
Director statistical programming, Astrazeneca
04:30-04:45 Q&A ALL
8 04:45-05:15 Quiz time Srikar Surapaneni,
Senior Regulatory Professional, Novo Nordisk
Rajesh Krishna,
Senior Regulatory Professional, Novo Nordisk
9 05:15-05:30 Closure IASCT Executive Council

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Note: Please contact Jagannatha P.S or Rashmi Jain for any queries related to registration.

Please add the mail subject as "IASCT Workshop - Mastering Regulatory Submissions: Best Practices and Compliance"

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