Canvas of Clinical Pharmacology Workshop - KEM Hospital

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Canvas of Clinical Pharmacology Workshop - KEM Hospital
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
Canvas of Clinical Pharmacology Workshop - KEM Hospital
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!
Canvas of Clinical Pharmacology Workshop - KEM Hospital
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
Canvas of Clinical Pharmacology Workshop - KEM Hospital
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
Canvas of Clinical Pharmacology Workshop - KEM Hospital
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)
Canvas of Clinical Pharmacology Workshop - KEM Hospital
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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