5th India Pharmaceutical Forum 2020





5th Advanced GMP Workshops 2020 Date: 04-06 November 2020

5th India Pharmaceutical Forum 2020 Date: 27-28 February 2020Location: Mumbai

5th Advanced GMP Workshops 2020 Date: 04-06 November 2020

5th India Pharmaceutical Forum 2020 Date: 27-28 February 2020Location: Mumbai

5th India Pharmaceutical Forum 2020 Date: 27-28 February 2020Location: Mumbai

Declan Byrne

Scientific Officer, Certification of Substances Division, EDQM

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Dilip Shanghvi

Managing Director, Sun Pharmaceutical Industries Limited

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Francis Godwin

Director, Office of Manufacturing Quality, Office of Compliance, CDER, USFDA

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Gautam Kumra

Managing Partner, McKinsey & Company

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Jaidev Rajpal

Partner, McKinsey & Company

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James Pound

Secretary & Scientific Director British Pharmacopoeia Commission,

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Jay Jariwala

Assistant Country Director (Drugs) India Office, USFDA

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Jeff Francer

Interim CEO and General Counsel, AAM

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Johnny Mikell

President of Global Quality and Compliance, Lupin Limited

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Matthias Spiegl

Associate Partner, McKinsey & Company

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Milind Joshi

President - Global Regulatory Management, JB Chemicals & Pharmaceuticals Ltd.

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Nilesh Deshbandhu Gupta

Managing Director and Executive Director to the Board Lupin Limited

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Pankaj R Patel

Chairman, Zydus Cadila

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Ranjana Pathak

President - Global Quality. Medical Affairs & Pharmacovigilance, Cipla

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Rubina Bose

Deputy Drugs Controller (India), CDSCO (West)

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Samantha Atkinson

Director of Inspection, Enforcement and Standards (IE&S),...

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Samina Vaziralli

Executive Vice Chairperson, Cipla Limited

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Satish Reddy

Chairman Dr Reddy's Laboratories Ltd.

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S G Belapure

Senior Technical Advisor, IPA

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Stelios C. Tsinontides

Director Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Pharmaceutical Quality, CDER USFDA

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Sudarshan Jain

Secretary General Indian Pharmaceutical Alliance

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Susan Schniepp

Chair-Elect PDA

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V G Somani

Drugs Controller General (India), Directorate General of Health Services

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Vikas Bhadoria

Senior Partner, McKinsey & Company

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Vipul Doshi

President - Group Quality Assurance & IRA, Pharmacovigilance and API R&D, Cadila Healthcare

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5th Advanced GMP Workshops 2020 – Guidelines

5th India Pharmaceutical Forum 2020 – Agenda

5th Advanced GMP Workshops 2020 Date: 04-06 November 2020

Session 2 :
Inspections in a post COVID-19 World Considerations

Dr Alonza Cruse

Session 2 :
Inspections in a post Covid-19 World Considerations

Mr Mark Birse

Session 3 :
New Developments in Biopharma Supply Chain

Mr Atul Mohidekar

Session 4 :
Assessment and Impact of EMA Annexure 1

Mr Glenn Wright, Mr Harold Baseman

Session 5 :
Technological Innovations in Manufacturing

Dr Thomas O’Connor

Session 5 :
Technological Innovations in Quality Assurance – Machine Learning and Applications

Dr Anupriya Balikai

Session 6 :
FDA 704(a)(4) Reviews – Inspections of Records

Dr Natalie Mickelsen

Session 8 :
Investigations of Human Errors – New Tools

Mr Vikram Shukla

Session 9 :
Advancements in Manufacturing Technology -Complex Injectables

Dr Alex George

Session 9 :
Advancements in Manufacturing Technology – Continuous Lyophilisation

Mr Dennis Posheluk

Session 9 :
Advancements in Manufacturing Technology Isolator Technology

Mr Thomas Arnegger

Session 10 :
Nitrosamine solving the Puzzle

Dr Edmond Biba

Session 10 :
Nitrosamine Solving the Puzzle

Dr Rajeev Mathur

5th India Pharmaceutical Forum 2020 Date: 27-28 February 2020Location: Mumbai

Day 1

Session 1 :
Welcome and Setting the Context

Mr Sudarshan Jain, IPA

Session 1 :
Inaugural Address

Mr Satish Reddy, Dr Reddy’s

Session 1 :
Release of IPA Guidelines on Market Complaints

 

Session 3 :
Quality and Patient Centricity

Mr Jeff Francer, AAM

Session 4 :
CDER / OC / OMQ Update and Recent Cross Contamination Case Studies

Mr Jeff Francer, AAM

Session 4 :
Surveillance Inspections and Recent Trends

Mr Jay Jariwala, USFDA (India)

Session 5 :
Quality by Design for Robust Product

Dr James Pound, MHRA

Session 5 :
Quality by Design for Robust Product

Mr Vipul Doshi, Cadila Healthcare

Session 6 :
Culture Transformation – Best Practices

Dr Samantha Atkinson, MHRA

Session 6 :
Culture Transformation – Best Practices

Ms Sue Schniepp, PDA

Session 6 :
Culture Transformation – Best Practices

Mr Johnny Mikell, Lupin

Day 2

Session 7 :
Commitment to Quality in Pharmaceutical Development and Commercial Manufacturing

Dr Stelios Tsinontides, USFDA

Session 7 :
Cost of Quality

Dr Ranjana Pathak, Cipla

Session 8 :
Global Best Practices in Capability Building

Mr Jaidev Rajpal, McKinsey & Co.

Session 8 :
Digital Technologies in Pharma Operations for Improved Quality

Mr Matthias Spiegl, McKinsey

Session 9 :
Nitrosamine Impurities – Current Status and Expectations

Dr Declan Byrne, EDQM

Session 9 :
Nitrosamine Impurities – Current Status and Expectations

Dr Milind Joshi, J B Chemicals