Canvas of Clinical Pharmacology Workshop 28 th January to 1 st February, 2019 (Monday through Friday)

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1 Canvas of Clinical Pharmacology Workshop 28 th January to 1 st February, 2019 (Monday through Friday) Organized and Conducted by: Department of Clinical Pharmacology Seth GSMC and KEMH, Mumbai Venue: Dr. Jivraj Mehta Lecture Theatre [JMLT], Ground Floor, College Building, Seth GSMC & KEMH, Mumbai

From the desk of Organizing Chairperson Dr.

pharmacologists for training in clinical pharmacology.

I, on behalf of the entire Department of Clinical Pharmacology, Seth GS Medical College, Mumbai would like to invite you to the Canvas of Clinical Pharmacology Workshop which promises to be

Mumbai, I promise you is a fun place to learn and we assure you a grand time. Give us this opportunity! Register in large numbers! From the desk of Scientific Chairperson Dr.

great strides this discipline would make in the decades to come.

2 From the desk of Organizing Chairperson Dr. Urmila Thatte Professor and Head Dept of Clinical Pharmacology Seth GSMC and KEMH When I was in a recent conference, I was impressed by what seemed to be an urgent need among young pharmacologists for training in clinical pharmacology. It is not possible to be trained in the entire subject in a short time, but I am pleased to announce a 5 day capsule that will give you a jolly good bird s eye view of the subject. I, on behalf of the entire Department of Clinical Pharmacology, Seth GS Medical College, Mumbai would like to invite you to the Canvas of Clinical Pharmacology Workshop which promises to be just that a canvas that will expose you to the facets of this subject that has been an integral part of much of my life. Mumbai, I promise you is a fun place to learn and we assure you a grand time. Give us this opportunity! Register in large numbers! From the desk of Scientific Chairperson Dr. Nithya Gogtay Additional Professor Dept of Clinical Pharmacology Seth GSMC and KEMH When Professor Harry Gold coined the term "Clinical Pharmacology", little would he have known about the great strides this discipline would make in the decades to come. Today, this discipline is so far reaching that it is difficult to imagine a world without Clinical Pharmacology and its myriad facets. The Canvas of Clinical Pharmacology workshop will take you through these facets one day at a time to show you just how far reaching the discipline is and therefore how far reaching your own careers can be. Each day has a central theme and beginning from clinical research, we will take you through real world evidence, artificial intelligence, risk based management, meta analysis and systematic reviews and non frightening statistics that shape evidence based medicine. Come and join us on this wonderful scientific journey of joyful learning and delight!

ORGANIZING COMMITTEE Chief Patron Dr. Hemant Deshmukh Dean Seth GSMC and KEMH Organizing Chairperson Dr. Urmila Thatte Professor and Head Scientific Chairperson Dr.

Mahesh Belhekar Co-Finance Secretary Dr. Parvan Shetty Registration Committee Dr. Unnati Saxena Dr. Jeffrey P Raj Dr Shruti Saha Logistics Committee Dr. Harshad Kesari Dr.

3 ORGANIZING COMMITTEE Chief Patron Dr. Hemant Deshmukh Dean Seth GSMC and KEMH Organizing Chairperson Dr. Urmila Thatte Professor and Head Scientific Chairperson Dr. Nithya Gogtay Additional Professor Organizing Secretary Dr. Mahanjit Konwar Joint Organizing Secretaries Dr. Kiran Khaladkar Dr. Debdipta Bose Finance Secretary Dr. Mahesh Belhekar Co-Finance Secretary Dr. Parvan Shetty Registration Committee Dr. Unnati Saxena Dr. Jeffrey P Raj Dr Shruti Saha Logistics Committee Dr. Harshad Kesari Dr. Nikhil Dhargawe Dr. Mitesh Maurya Contact details Dept of Clinical Pharmacology Seth GSMC and KEMH Dr. Mahanjit Konwar : Dr. Kiran Khaladkar : Dr. Debdipta Bose :

4 Day 1: Clinical Research Monday, 28/01/2019 Time [hrs] Topic Speakers Breakfast Inauguration Future of Clinical Research Industry in India The Era of Biosimilars- Where does India Stand? Patient Centric Approach in Clinical Research IPR Issues in Pharma Sector: How are they Addressed? Dr. Viraj Suvarna Vice President Eris Lifesciences Dr. Sonica Sachdeva Batra Senior Director & Head, Medical Sciences Biologics, DRL TBD* Dr. Apurba Mukherjee Associate Vice President Astellas Pharma India Tea Break Adaptive Clinical Trials: Progress and Challenges Real World Evidence Studies Dr Mahesh Iyer Co-founder Sineflex Solutions Dr. Shalaka Marfatia Director Health Economics and Outcomes Research, Pharma edge Lunch Challenges and Quality Management in Clinical Trials Designing Phase I and Phase II Trials [Hands-on Training] Shehnaz Vakharia Managing Director, ADAMAS Consulting Dr.Bhagwat Gunale Assistant General manager Serum Institute Pune Dr Arun Bhatt Consultant Clinical Research Tea Break Designing Phase I and Phase II Trials [Hands-on Training] Dr. Vikram Gota Professor & Officer-in-Charge Dept of Clinical Pharmacology ACTREC Mumbai * To Be Decided

5 Day 2: Clinical Trials Tuesday, 29/01/2019 Time [hrs] Topic Speakers Breakfast Artificial Intelligence in Pharmacovigilance - Current Trends Dr Krishna Asvalayan Director- Anclacorp Course of Action when Primary Outcome is NOT Significant in Clinical Trials Designing Clinical Trials for Safety : Evaluating QTc interval in clinical trials Risk Based Monitoring in Clinical Trial Dr. Suresh Menon Medical Director Novartis Pharmaceuticals Dr. D Karnad Jupiter Hospital, Thane Murugananthan K Country Monitoring Head, Global Development Operation, Novartis Handling of Missing Data in Clinical Trials Novel Trial Designs in Precision Medicine Tea Break Dr. Samir Malhotra, Professor Dept of Pharmacology PGIMER Chandigarh Dr. Anil Kukreja Medical Director, Roche India Lunch Study Designs (Superiority, Non-inferiority and Equivalence ) Dr. Jaideep Gogtay Head, Medical Services Cipla Tea Break Study Designs (Superiority, Non-inferiority and Equivalence ) Dr. Jaideep Gogtay Head, Medical Services Cipla

6 Day 3: Health Economics and Outcomes Research Wednesday, 30/01/2019 Time [hrs] Topic Speakers Breakfast Health Economics and Outcomes Research in India: Scope Cost-minimization and Cost Consequence Analysis Trials Cost-effectiveness Analysis and Cost Utility Trials Mahendra Rai Head R&D commercial Solutions, RWI, IQVIA Richa Goyal Associate Director, HEOR, IQVIA Mahendra Rai Head R&D commercial Solutions, RWI, IQVIA HRQOL in Clinical Trials Sunil Singh Senior Manager, ACG Tea Break Global Drug Pricing Drug Utilization Studies Dr.Somnath Datta Franchise Head-Immunology, Janssen India Dr. Ashish Pathak Professor of Paediatrics Ujjain Lunch Budget Impact Assessment Richa Goyal Associate Director, HEOR, IQVIA Using Multi-criteria Decision Analysis in Health Care Decision Making: Approaches and Applications Mahendra Rai Head R&D commercial Solutions, RWI, IQVIA Tea Break Using Multi-criteria Decision Analysis in Health Care Decision Making: Approaches and Applications Sunil Singh Senior Manager, ACG

7 Day 4: Statistics beyond p-value Thursday, 31/01/2019 Time [hrs] Topic Speakers Breakfast p-value & Confidence Interval Dr. Nithya Gogtay Additional Professor Dept of Clinical Pharmacology KEMH *2 Tables in Statistics Dr J P Muliyil Retired Principal CMC Vellore Tea Break Linear, Logistic and Multivariate Regression Dr. L. Jeyaseelan Professor Dept of Statistics CMC Vellore Lunch Survival Analysis and Cox-proportional Regression Model Dr. L. Jeyaseelan Professor Dept of Statistics CMC Vellore Tea Break Survival Analysis and Cox-proportional Regression Model Dr. L. Jeyaseelan Professor Dept of Statistics CMC Vellore

8 Day 5: Systematic Reviews & Meta-analysis Friday, 01/02/2019 Time [hrs] Topic Speakers Breakfast Meta-analysis and Network Metaanalysis A Paradigm Shift in Evidence Based Medicine Dr P Tharyan Director at South Asian Cochrane Centre Tea Break Effective Literature Search (Hands-on training) Vasumathi Sriganesh Director QMed Services Pvt Ltd Hands-on Training using RevMan 5 Software (Meta-analysis Of Binary Data) Dr P Tharyan Director at South Asian Cochrane Centre Lunch Hands-on Training using RevMan 5 Software (Meta-analysis of Continuous Data) Dr P Tharyan Director at South Asian Cochrane Centre Tea Break Valedictory and Distribution of Certificates

9 TRAVEL INFORMATION Seth G.S. Medical College and KEM Hospital is located in Parel, South Central Mumbai. It is very well connected by all transport routes. Taxi should be preferred over Mumbai Local trains for non-mumbai delegates. Also please keep in mind the traffic during peak hours. Place Distance to KEM ACCOMMODATION Approximate time by taxi Mumbai Airport 15 kms 45 mins - 1hr Chhatrapati Shivaji Terminus (CST) 7.3 kms mins Dadar Terminus 3 kms 10 mins Lokamanya Tilak Terminus, Kurla 11 kms mins Mumbai Central Railway station 5.2 kms mins The delegate fees DO NOT include accommodation. Delegates are requested to make their own arrangements. For any queries related to logistics, please at ccpw2019@gmail.com or call Dr. Harshad Kesari : Dr. Nikhil Dhargawe : Dr. Mitesh Maurya :

APPLICATION FORM Note: Please fill up the google form for registration. https://tinyurl.

Candidates selected will be notified over email and will be provided bank details for payment of registration fees.

10 APPLICATION FORM Note: Please fill up the google form for registration. Submission of application doesn t guarantee acceptance into the workshop. Candidates selected will be notified over and will be provided bank details for payment of registration fees. Delegates Fees Students 7501/- Faculty 10001/- Industry 15001/- CME credit points for eligible candidates : Applied for MMC credit points Registration acknowledgement and other correspondence will be done by only. For any queries related to registration, at - ccpw.19.reg@gmail.com or call Dr. Unnati Saxena : Dr. Shruti Saha : Dr. Jeffrey P Raj :

Pre- conference Workshop 2 30th April, 2018 Prescribing skills, research, training and assessment

11 th Annual Conference of South Asian College of Clinical Pharmacology (An affiliate of American College of Clinical Pharmacology) (29 th April 2 nd May) Pre- conference Workshop 2 30th April, 2018 Prescribing