Data Integrity: Hype, Myth, Fallacies and Reality Umesh Banakar, Professor and President, Banakar Consulting Services
14:35
Q/A
14:40
IT Compliance in Bio-Equivalence Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd
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.
15:45
Q/A
15:50
"Compliance - A New Jargon in Clinical Research" - A Sponsor Perspective Radhika Inapakolla, Asst. Director, Lupin Limited
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
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
09:45
Q/A
09:50
How to Face Regulatory Inspections Efficiently? Ramakrishna Bangaru, Sr. Vice President, Mylan Laboratories
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
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
12:00
Q/A
12:05
GCP/GLP & Other Requirements for CT/BE Studies J Ramniwas, CEO & Managing Consultant, Sai Pharma Solutions Inc
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
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
15:40
Q/A
15:45
Leveraging Innovation in Generics Anil Pareek, President, Ipca Laboratories Ltd