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JULY 10 - 11 / 09:30 AM - 01:30 PM

Workshop on Impact of COVID 19 on the Regulatory Environment

For all students, faculty and research scholars willing to stay abreast of the regulatory environment in the country as well as globally.

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WHEN

July 10 & 11, 2020

Objectives

  • The workshop is aimed at discussing the dynamic changes, challenges and opportunities in the global regulatory environment which resulted due to the changes in the pharmaceutical and healthcare sector as a result of ongoing pandemic. 

Eminent Speakers

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Dr. AKS Bhujanga Rao

Dr.Reddy's Laboratories Limited

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Dr. Premnath Shenoy

President IPA, Karnataka Branch

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G. Sangeetha

Head, Regulatory Affairs, Hetero Drugs

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Dr. Navneetha Selvan

Senior General Manager,

Wockhardt

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Dr. Srinivas Nanduri

Professor, NIPER Hyderabad

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Ms. Ch. Lakshmi Prasanna

Senior Regulatory Officer,

Pharmexcil

SCHEDULE

Day 1 - 10/07/2020

09:30 AM-09:40 AM

​Webinar - Dr. Shashi Bala Singh

  • Welcome address

09:40 AM-10:40 AM

​Webinar - Dr. A. K. S. Bhujanga Rao

  • Regulatory Compliance in the Pharma Industry—An Overview

10:40 AM-11:40 AM

​Webinar - Dr. Premnath Shenoy

  • Impact of Covid pandemic on Regulatory agencies and Pharmaceutical Industry opportunities and challenges

11:40 AM-12:40 PM

​Webinar - Ms. Sangeetha

  • IND and NDA in USA & EU

Day 2 - 11/07/2020

09:30 AM-10:15 AM

​Webinar - Dr. Navaneetha Selvan

  • An overview of global registration requirements for Biosimilar

10:15 AM-11:00 AM

​Webinar - Ms.Sangeetha

  • An introduction to CTD and eCTD for generic Products

11:00 PM-11:15 AM

​Webinar - Short Break

  • ​

11:15 AM-12:00 PM

​Webinar - Dr. Premnath Shenoy

  • Key changes in revised Schedule M - a perspective

12:00 PM-12:45 PM

​Webinar - Ms. Ch.Lakshmi Prasanna

  • Regulatory requirements for New Drugs and clinical trails- Indian perspective

12:45 PM-01:30 PM

​Webinar - Prof. Srinivas Nanduri

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Organizing Committee

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Dr. Shashi Bala Singh

Director, NIPER Hyderabad

Chairperson, Organizing Committee

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Dr. Y.V.Madhavi

Assistant Professor, NIPER Hyderabad

Convenor, Organizing Committee

Registration Details:

Mode of Payment:

Please pay using Online methods to the below bank account.
                                     
  Account Name: NIPERH   Resources
  Bank Name: State Bank of India
  Branch: IDPL Colony branch
  Account Number: 37787539689
  Swift Code: SBININBBH19
  IFSC Code: SBIN0020245 
  MICR Number: 50000
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Please share a screenshot of the transaction id after making payment to the email id wicreworkshopniper@gmail.com

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