Shopping Cart (0)
My Account

Shopping Cart
SELECTBIO Conferences Quality, Compliance & Audit in Clinical Trials

Quality, Compliance & Audit in Clinical Trials Agenda



Co-Located Conference Agendas

Novel Formulation Strategies | Quality, Compliance & Audit in Clinical Trials | 

Print Agenda

Thursday, 12 April 2018

08:00

Registration

09:15

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

09:25

Introduction of Resource Persons & Memento Presentation

09:45

Card Exchange and Networking Session

10:00

Group Photograph

10:10

Coffee Break and Networking in Exhibition Area

10:40

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

11:15

Q/A

11:20

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

11:50

Q/A

11:55

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

12:25

Q/A

12:30

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

13:00

Q/A

13:05

Lunch and Networking in Exhibition Area

14:05

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

14:35

Q/A

14:40

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

15:10

Q/A

15:15

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

15:45

Q/A

15:50

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

16:20

Q/A

16:25

Coffee Break and Networking in Exhibition Area

16:45

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



16:47

Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd, India

16:49

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

16:51

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

16:53

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

16:53

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

17:20

Conference Feedback

17:30

End of Day 1 Proceedings

Friday, 13 April 2018

09:15

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

09:45

Q/A

09:50

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

10:20

Q/A

10:25

Coffee Break and Networking in Exhibition Area

10:55

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

11:25

Q/A

11:30

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

12:00

Q/A

12:05

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

12:35

Q/A

12:40

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.

13:40

Lunch and Networking in Exhibition Area

14:40

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

15:05

Q/A

15:10

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

15:40

Q/A

15:45

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

16:15

Q/A

16:20

Conference Feedback

16:30

Closing Remarks and Vote of Thanks

16:35

Farewell Coffee


Add to Calendar ▼2018-04-12 00:00:002018-04-13 00:00:00Europe/LondonQuality, Compliance and Audit in Clinical TrialsQuality, Compliance and Audit in Clinical Trials in MumbaiMumbaiSELECTBIOenquiries@selectbiosciences.com