Quality, Compliance & Audit in Clinical Trials Agenda

Registration

Welcome Address
Sanjay Bajaj, MD, Select Biosciences India Pvt Ltd, India

Introduction of Resource Persons & Memento Presentation

Card Exchange and Networking Session

Group Photograph

Coffee Break and Networking in Exhibition Area

WHO PQ Inspection Experience of CROs
Vimal Sachdeva, Lead Inspector (Technical Officer), World Health Organization, Switzerland

Q/A

Regulatory Amendments and SAE Reporting with respect to CT and BE Studies
Mita Nandy, Consultant, Central Drugs Standard Control Organization, India

Q/A

ICH E6 R2 Addendum : Impact on India
Arun Bhatt, Consultant, Clinical Research & Development, India

Q/A

CDISC Overview in Bio-Equivalence Studies
Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd , India

Q/A

Lunch and Networking in Exhibition Area

Data Integrity: Hype, Myth, Fallacies and Reality
Umesh Banakar, Professor and President, Banakar Consulting Services, United States of America

Q/A

IT Compliance in Bio-Equivalence
Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd , India

Q/A

CRO-Sponsor Collaboration, A Different Way is Possible
Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A., Spain

Q/A

"Compliance - A New Jargon in Clinical Research" - A Sponsor Perspective
Radhika Inapakolla, Asst. Director, Lupin Limited, India

Q/A

Coffee Break and Networking in Exhibition Area

Panel Discussion: Quality of Clinical Study Data - Regulatory Updates and CRO/Sponsor's Perspective
Sanjay Bajaj, Managing Director, Select Biosciences India Pvt Ltd, India

Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd, India

Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A., Spain

Mita Nandy, Consultant, Central Drugs Standard Control Organization, India

Ramakrishna Bangaru, Sr. Vice President, Mylan Laboratories, India

Vimal Sachdeva, Lead Inspector (Technical Officer), World Health Organization, Switzerland

Conference Feedback

End of Day 1 Proceedings

Handling Internal Audits
Bobby George, Vice President & Head Regulatory Affairs, Reliance Life Sciences Pvt Ltd, India

Q/A

How to Face Regulatory Inspections Efficiently?
Ramakrishna Bangaru, Sr. Vice President, Mylan Laboratories, India

Q/A

Coffee Break and Networking in Exhibition Area

WHO Guidance on Good Data and Records Management Practices
Vimal Sachdeva, Lead Inspector (Technical Officer), World Health Organization, Switzerland

Q/A

Guide on Selecting CRO and How to Avoid Financial Losses in BE Study
Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd, India

Q/A

GCP/GLP & Other Requirements for CT/BE Studies
J Ramniwas, CEO & Managing Consultant, Sai Pharma Solutions Inc, India

Q/A

Interactive Session: This is going to be a special designed interactive session wherein, the delegates will get an excellent opportunity to interact with the renowned experts/speakers in an informal open session.

Lunch and Networking in Exhibition Area

Root Cause Investigations of Data Integrity Issues
Amer Alghabban, Vice President, Karyopharm Therapeutics, Switzerland

Q/A

USFDA Warning Letters - How to Respond?
Elayaraja Natarajan, Associate Director – Quality Assurance and Formulation Development, Rubicon Research Pvt Ltd, India

Q/A

Leveraging Innovation in Generics
Anil Pareek, President, Ipca Laboratories Ltd, India

Q/A

Conference Feedback

Closing Remarks and Vote of Thanks

Farewell Coffee