Canvas of Clinical Pharmacology Workshop - KEM Hospital
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Canvas of Clinical Pharmacology Workshop 28th January to 1st 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 When I was in a recent conference, I was impressed Organizing Chairperson by what seemed to be an urgent need among young Dr. Urmila Thatte pharmacologists for training in clinical Professor and Head Dept of Clinical Pharmacology pharmacology. It is not possible to be trained in the Seth GSMC and KEMH 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 When Professor Harry Gold coined the term "Clinical Pharmacology" , little would he have known about the Scientific Chairperson Dr. Nithya Gogtay great strides this discipline would make in the Additional Professor decades to come. Today, this discipline is so far Dept of Clinical Pharmacology reaching that it is difficult to imagine a world without Seth GSMC and KEMH 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 Scientific Chairperson Dr. Urmila Thatte Dr. Nithya Gogtay Professor and Head Additional Professor Organizing Secretary Joint Organizing Dr. Mahanjit Konwar Secretaries Dr. Kiran Khaladkar Dr. Debdipta Bose Finance Secretary Co-Finance Secretary Dr. Mahesh Belhekar Dr. Parvan Shetty Registration Committee Logistics Committee Dr. Unnati Saxena Dr. Harshad Kesari Dr. Jeffrey P Raj Dr. Nikhil Dhargawe Dr Shruti Saha 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 Dr. Viraj Suvarna Future of Clinical Research Industry in 0900 - 0930 Vice President India Eris Lifesciences Dr. Sonica Sachdeva Batra The Era of Biosimilars- Where does 0930 – 1000 Senior Director & Head, Medical Sciences India Stand? Biologics, DRL Patient Centric Approach in Clinical 1000 – 1030 TBD* Research Dr. Apurba Mukherjee IPR Issues in Pharma Sector: How are 1030 – 1100 Associate Vice President they Addressed? Astellas Pharma India 1100 – 1115 Tea Break Adaptive Clinical Trials: Progress and Dr Mahesh Iyer 1115 – 1200 Challenges Co-founder Sineflex Solutions Dr. Shalaka Marfatia 1200 – 1245 Real World Evidence Studies Director Health Economics and Outcomes Research, Pharma edge 1245 – 1345 Lunch Challenges and Quality Shehnaz Vakharia 1345 – 1415 Management in Clinical Trials Managing Director, ADAMAS Consulting Dr.Bhagwat Gunale Assistant General manager Designing Phase I and Phase II Trials 1415 – 1545 Serum Institute Pune [Hands-on Training] Dr Arun Bhatt Consultant Clinical Research 1545 – 1600 Tea Break Dr. Vikram Gota Designing Phase I and Phase II Trials Professor & Officer-in-Charge 1600 – 1700 Dept of Clinical Pharmacology [Hands-on Training] ACTREC Mumbai * To Be Decided
Day 2: Clinical Trials Tuesday, 29/01/2019 Time [hrs] Topic Speakers 0830 – 0900 Breakfast Artificial Intelligence in Dr Krishna Asvalayan 0900 – 0930 Director- Anclacorp Pharmacovigilance - Current Trends Course of Action when Primary Dr. Suresh Menon 0930 – 1000 Outcome is NOT Significant in Clinical Medical Director Novartis Pharmaceuticals Trials Designing Clinical Trials for Safety : Dr. D Karnad 1000 – 1030 Evaluating QTc interval in clinical Jupiter Hospital, Thane trials Murugananthan K 1100 – 1115 Risk Based Monitoring in Clinical Trial Country Monitoring Head, Global Development Operation, Novartis Tea Break Dr. Samir Malhotra, Professor Handling of Missing Data in Clinical 1115 – 1215 Dept of Pharmacology Trials PGIMER Chandigarh Novel Trial Designs in Precision Dr. Anil Kukreja 1215 – 1300 Medicine Medical Director, Roche India 1300 – 1400 Lunch Study Designs (Superiority, Non-inferiority and Dr. Jaideep Gogtay 1400 – 1600 Equivalence ) Head, Medical Services Cipla (Hands-on Training) 1600 – 1615 Tea Break Study Designs (Superiority, Non-inferiority and Dr. Jaideep Gogtay 1615 – 1700 Equivalence ) Head, Medical Services Cipla (Hands-on Training)
Day 3: Health Economics and Outcomes Research Wednesday, 30/01/2019 Time [hrs] Topic Speakers 0830 – 0900 Breakfast Mahendra Rai Health Economics and Outcomes 0900 – 0920 Head R&D commercial Solutions, RWI, Research in India: Scope IQVIA Richa Goyal Cost-minimization and Cost 0920 -1000 Associate Director, Consequence Analysis Trials HEOR, IQVIA Mahendra Rai Cost-effectiveness Analysis and Cost 1000– 1045 Head R&D commercial Solutions, RWI, Utility Trials IQVIA 1045-1115 HRQOL in Clinical Trials Sunil Singh Senior Manager, ACG 1115 – 1130 Tea Break Dr.Somnath Datta 1130 – 1200 Global Drug Pricing Franchise Head-Immunology, Janssen India Dr. Ashish Pathak 1200 – 1300 Drug Utilization Studies Professor of Paediatrics Ujjain 1300 – 1400 Lunch Richa Goyal 1400 – 1445 Budget Impact Assessment Associate Director, HEOR, IQVIA Using Multi-criteria Decision Analysis in Mahendra Rai Health Care Decision Making: 1445 – 1545 Head R&D commercial Solutions, RWI, Approaches and Applications IQVIA (Hands-on Training) 1545-1600 Tea Break Using Multi-criteria Decision Analysis in Sunil Singh 1600 – 1700 Health Care Decision Making: Senior Manager, ACG Approaches and Applications (Hands-on Training)
Day 4: Statistics beyond p-value Thursday, 31/01/2019 Time [hrs] Topic Speakers 0830 – 0900 Breakfast Dr. Nithya Gogtay Additional Professor 0900 – 0945 p-value & Confidence Interval Dept of Clinical Pharmacology KEMH 0945– 1100 2*2 Tables in Statistics Dr J P Muliyil (Hands-on Training) Retired Principal CMC Vellore 1100 – 1115 Tea Break Dr. L. Jeyaseelan Linear, Logistic and Multivariate Professor Dept of Statistics 1115 – 1315 Regression CMC Vellore (Hands-on Training) 1315 – 1415 Lunch Dr. L. Jeyaseelan Survival Analysis and Cox-proportional Professor Dept of Statistics 1415 – 1545 Regression Model CMC Vellore (Hands-on Training) 1545-1600 Tea Break Dr. L. Jeyaseelan Survival Analysis and Cox-proportional Professor Dept of Statistics 1600-1700 Regression Model CMC Vellore (Hands-on Training)
Day 5: Systematic Reviews & Meta-analysis Friday, 01/02/2019 Time [hrs] Topic Speakers 0830 – 0900 Breakfast Meta-analysis and Network Meta- Dr P Tharyan analysis 0900 – 1030 Director at South Asian Cochrane A Paradigm Shift in Evidence Based Centre Medicine 1030-1045 Tea Break Vasumathi Sriganesh Effective Literature Search 1045-1145 Director QMed Services (Hands-on training) Pvt Ltd Hands-on Training using RevMan 5 Dr P Tharyan 1130-1300 Software Director at South Asian Cochrane (Meta-analysis Of Binary Data) Centre 1300 – 1400 Lunch Hands-on Training using RevMan 5 Dr P Tharyan 1400 – 1600 Software Director at South Asian Cochrane (Meta-analysis of Continuous Data) 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 Approximate time by taxi KEM 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 ACCOMMODATION 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
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