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 - 400012
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. 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 : 7678250166 Dr. Kiran Khaladkar : 7045358351 Dr. Debdipta Bose : 8105353421
Day 1: Clinical Research Monday, 28/01/2019 Time [hrs] Topic Speakers 0830 0845 Breakfast 0845 0900 Inauguration 0900-0930 0930 1000 1000 1030 1030 1100 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 1100 1115 Tea Break 1115 1200 Adaptive Clinical Trials: Progress and Challenges 1200 1245 Real World Evidence Studies Dr Mahesh Iyer Co-founder Sineflex Solutions Dr. Shalaka Marfatia Director Health Economics and Outcomes Research, Pharma edge 1245 1345 Lunch 1345 1415 1415 1545 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 1545 1600 Tea Break 1600 1700 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
Day 2: Clinical Trials Tuesday, 29/01/2019 Time [hrs] Topic Speakers 0830 0900 Breakfast 0900 0930 Artificial Intelligence in Pharmacovigilance - Current Trends Dr Krishna Asvalayan Director- Anclacorp Course of Action when Primary 0930 1000 Outcome is NOT Significant in Clinical Trials Designing Clinical Trials for Safety : 1000 1030 Evaluating QTc interval in clinical trials 1100 1115 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 1115 1215 1215 1300 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 1300 1400 Lunch 1400 1600 Study Designs (Superiority, Non-inferiority and Equivalence ) Dr. Jaideep Gogtay Head, Medical Services Cipla 1600 1615 Tea Break 1615 1700 Study Designs (Superiority, Non-inferiority and Equivalence ) Dr. Jaideep Gogtay Head, Medical Services Cipla
Day 3: Health Economics and Outcomes Research Wednesday, 30/01/2019 Time [hrs] Topic Speakers 0830 0900 Breakfast 0900 0920 0920-1000 1000 1045 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 1045-1115 HRQOL in Clinical Trials Sunil Singh Senior Manager, ACG 1115 1130 Tea Break 1130 1200 Global Drug Pricing 1200 1300 Drug Utilization Studies Dr.Somnath Datta Franchise Head-Immunology, Janssen India Dr. Ashish Pathak Professor of Paediatrics Ujjain 1300 1400 Lunch 1400 1445 Budget Impact Assessment Richa Goyal Associate Director, HEOR, IQVIA 1445 1545 Using Multi-criteria Decision Analysis in Health Care Decision Making: Approaches and Applications Mahendra Rai Head R&D commercial Solutions, RWI, IQVIA 1545-1600 Tea Break 1600 1700 Using Multi-criteria Decision Analysis in Health Care Decision Making: Approaches and Applications Sunil Singh Senior Manager, ACG
Day 4: Statistics beyond p-value Thursday, 31/01/2019 Time [hrs] Topic Speakers 0830 0900 Breakfast 0900 0945 p-value & Confidence Interval Dr. Nithya Gogtay Additional Professor Dept of Clinical Pharmacology KEMH 0945 1100 2*2 Tables in Statistics Dr J P Muliyil Retired Principal CMC Vellore 1100 1115 Tea Break 1115 1315 Linear, Logistic and Multivariate Regression Dr. L. Jeyaseelan Professor Dept of Statistics CMC Vellore 1315 1415 Lunch 1415 1545 Survival Analysis and Cox-proportional Regression Model Dr. L. Jeyaseelan Professor Dept of Statistics CMC Vellore 1545-1600 Tea Break 1600-1700 Survival Analysis and Cox-proportional Regression Model Dr. L. Jeyaseelan Professor Dept of Statistics CMC Vellore
Day 5: Systematic Reviews & Meta-analysis Friday, 01/02/2019 Time [hrs] Topic Speakers 0830 0900 Breakfast 0900 1030 Meta-analysis and Network Metaanalysis A Paradigm Shift in Evidence Based Medicine Dr P Tharyan Director at South Asian Cochrane Centre 1030-1045 Tea Break 1045-1145 Effective Literature Search (Hands-on training) Vasumathi Sriganesh Director QMed Services Pvt Ltd 1130-1300 Hands-on Training using RevMan 5 Software (Meta-analysis Of Binary Data) Dr P Tharyan Director at South Asian Cochrane Centre 1300 1400 Lunch 1400 1600 Hands-on Training using RevMan 5 Software (Meta-analysis of Continuous Data) Dr P Tharyan Director at South Asian Cochrane Centre 1600-1615 Tea Break 1615 1700 Valedictory and Distribution of Certificates
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 20-30 mins Dadar Terminus 3 kms 10 mins Lokamanya Tilak Terminus, Kurla 11 kms 30-40 mins Mumbai Central Railway station 5.2 kms 20-30 mins The delegate fees DO NOT include accommodation. Delegates are requested to make their own arrangements. For any queries related to logistics, please email at ccpw2019@gmail.com or call Dr. Harshad Kesari : 8149414966 Dr. Nikhil Dhargawe : 9975155692 Dr. Mitesh Maurya : 9167612373
APPLICATION FORM Note: Please fill up the google form for registration. https://tinyurl.com/ybpul7gd Submission of application doesn t guarantee acceptance into the workshop. Candidates selected will be notified over email 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 email only. For any queries related to registration, email at - ccpw.19.reg@gmail.com or call Dr. Unnati Saxena : 9005268949 Dr. Shruti Saha : 7087653217 Dr. Jeffrey P Raj : 7904286189