SELECTBIO - Quality, Compliance & Audit in Clinical Trials 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