INDIAN SOCIETY FOR CLINICAL RESEARCH 11th Annual ISCR Conference Collaborative Clinical Research for better Patient outcomes January, 2018

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Agenda: Friday, 19th January 2018 07:30-17:00. INDIAN SOCIETY FOR CLINICAL RESEARCH 11th Annual ISCR Conference Collaborative Clinical Research for better Patient outcomes 19-20 January, 2018 Hotel J.

1 Agenda: Friday, 19th January :30-17:00. INDIAN SOCIETY FOR CLINICAL RESEARCH 11th Annual ISCR Conference Collaborative Clinical Research for better Patient outcomes January, 2018 Hotel J. W. Marriott, Bengaluru Registration (For Faculty, Speakers, Delegates and Participants) Session 1 09:00-10:00 Inauguration Welcome and Address by Dr. Chirag Trivedi, President, ISCR, followed by report from Dr Sanish Davis, General Secretary, ISCR Scientific Programme overview by Dr. Denis Xavier, Chair, Scientific Committee Introduction to Chief Guest (Prof P.P. Bapsy, Formerly at Kidwai and Apollo Hospitals, Bengaluru) Chief Guests address ISCR Excellence Awards for Academia and Industry Vote of Thanks by Dr. Ramesh Jagannathan, Chair, Organizing Committee Session 2 10:00-11:00 Key Note Oration Prof Ranjit Roy Chaudhury Oration

2 Orator: Dr. Anil Koul, Director for Institute of Microbial Technology (IMTECH), Chandigarh, INDIA Oration Title: Discovery and Development of Bedaquiline- A new drug for drug-resistant tuberculosis - Harnessing value of Innovation 11:00-11:30 Coffee / Tea and Networking Session 3 (Clinical Research Track Main Hall) 11:30-13:00 13:00-14:00 14:00 15:30 Conference Theme-Based Expert Panel Discussion Collaborative Clinical Research for better Patient outcomes Chairperson: Prof. Denis Xavier (St. John s, Bengaluru) Speaker: Prof. Shyam Sundar (BHU, Varanasi) Title: Development of Treatments for Visceral Leishmaniasis Expert Panel Members: CDSCO official, Prof. Prem Pais (Manipal Hospital, Bengaluru), Prof. Shyam Sundar (BHU, Varanasi), Prof. Urmila Thatte (Seth G.S. Medical College, Mumbai), Dr. Venugopal K. Nair (Pushpagiri Institute of Medical Sciences, Cochin) Dr. Suresh Menon (Novartis, Mumbai) Lunch and Networking Session 4 (Clinical Research Track Main Hall) Session Theme: Winds of change: Collaborative regulatory framework for better patient outcomes Session objective: To focus will be on recent regulatory changes for conduct of clinical research and clinical trials in India, and its impact on various stakeholders What is working well and what the areas that need further change or improvement Chairperson: Dr. Suresh Menon (Novartis, Mumbai) Expert Panel Members: CDSCO official, Prof. Y. K. Gupta (AIIMS, New Delhi), Prof. Chittaranjan Andrade (NIMHANS, Bengaluru), Dr. Roli Mathur (ICMR, Bengaluru), Dr. Srikanth K. (Sri Bala Hospital, Coimbatore), Dr. Shashwati Devsharma (Pfizer, Mumbai)

3 16:00 17:30. Session 5 (Clinical Research Track Main Hall) Session Theme: High quality conduct of clinical trials to enhance patients outcome Session Objective: To present and discuss clinical trials topics of current interest, opportunities and challenges with focus on industry perspective and collaboration with stakeholders for better patient outcomes Chairpersons and Moderators: Dr Arun Bhatt (Formerly ClinInvent, Mumbai), Dr. Amarnath Sharma (Janssen, USA) Topics and Speakers: 1. ICH-GCP E6 (R2): Its impact on Sponsors, Investigators and collaboration in clinical research Ms. Shehnaz Vakharia (ADAMAS, Mumbai) 2. Risk-Based Monitoring (RBM) for efficient conduct of clinical trials Dr. Veena Jaguste (Formerly Amgen, Mumbai) 3. International perspectives on Indian sites and patients in global clinical trials past, present and future Dr. Marisa Petersen (George Clinical, Australia) 4. Clinical development with Biologics and Bio-similars for better treatment options for patients Dr. Ammar Raza (Allergan, Bengaluru) 18:00-19:30 20:00 22:00 ISCR Annual General Body Meeting GALA DINNER

4 11th Annual ISCR Conference Saturday, 20th January 2018 Hotel J. W. Marriott, Bengaluru Agenda: Saturday, 20th January 2018 Registration (For Faculty, Speakers, Delegates and Participants) 08:00-12:00 Session 6 (Clinical Research Track Main Hall) 09:00-10:30 Session Theme: Patients in Clinical Research - Connect and Perspectives Chairpersons: Dr. Rajiv Parakh (Medanta, Gurgaon), Dr. P.P. Mohanan (Westfort Hi-Tech Hospital, Thrissur) Session Objective: The speakers (Including 1-2 patients) will focus on patients experience in clinical trials, clinical research and their insights into how participation in clinical trial(s) had had positive impact for them and further led to drug being available in India will be discussed Topics and Speakers: 1. Experience of conduct of VTE trials in India- Key aspects leading to success for India : Dr. Parakh (Medanta, Gurgaon) 2. Experience of conduct of AF trials in India : Dr. Abraham Oomman (Apollo, Chennai) 3. Discussion with AF/VTE patient/s who participated in the AF/VTE trial(s): Two Patient (s) 4. Large-scale academia-led CVD studies in India: Dr. Ambuj Roy (AIIMS, New Delhi) Q and A with Investigators/doctors and/their Patients, and from audience Session 7 (Clinical Research Track Main Hall) Session Theme: Academia and Investigator-led Collaborative research with focus on Indian patients 11:00-11:50 Key Note Oration Dr. V. Mohan (Chairman, Madras Diabetes Research Foundation and Dr. Mohan s Diabetes Centres, Chennai) Topic: My Journey in Diabetes Research: The power of Collaboration with all stakeholders

5 11:50 13:00 Chairpersons: Prof. Prem Pais (Manipal Hospital, Bengaluru), Dr. Sundeep Salvi (Chest Research Foundation, Pune) Session Objective: The Academic Faculty and Speakers will present and share their Institution and collaborative group experience in both interventional studies and epidemiological research and focus on collaboration which led to better outcomes for patients. Three to four short presentations will be followed by an Expert Panel Discussion. Topics and Speakers: 1. Investigator-led Clinical research in Respiratory Diseases Prof. (Dr.) George D Souza (St. John s, Bengaluru) 2. ICMR-led collaborative research in Cardio-vascular diseases (CVDs) Dr. Meenakshi Sharma (ICMR, New Delhi) 3. Large observational epidemiological studies in CVD: How collaborations led to better understanding Dr. Rajeev Gupta (Eternal Hospital, Jaipur) 4. Research in stem cells and hemato-oncology: Importance of collaborating with all stakeholders Dr. Sharat Damodar (Mazumdar Shaw Medical Center, Bengaluru) Panel Discussion: All Speakers plus Dr Surya Kant (KGMC, Lucknow) 13: Lunch and Networking Session 8 (2 Parallel sessions) Session Theme: Addressing important areas in Clinical Research (Focus on Young researchers and PG Students) Chairpersons: Dr. Usharani P. (NIMS, Hyderabad) and Anirban Roy Chowdhury (MSD, Gurgaon) (Session 1) Dr. Srikanth K. (Sri Bala Hospital, Coimbatore) and Dr. Shoibal Mukherjee (Formerly Quintiles, Gurgaon) (Session 2) Upto Ten Oral Presentations Selected from submitted Abstracts (Parallel Session) Tea break Session 9 (Clinical Research Track Main Hall)

6 Session Theme: Innovations in Medical Devices and Clinical Research for enhanced Patient outcomes Session Objective: To discuss topics of current and future interest in Clinical Research with focus on Medical Devices Chairpersons: Dr Surinder Kher (HCG, Bengaluru), Dr Jagdish Chaturvedi (Fortis, Bengaluru) Session Topics and Speakers: 1. Artificial Intelligence (AI) in Healthcare: What to expect in Clinical Research for Better Patient Outcomes Dr. Geetha Manjunath (NIRAMAI, Bengaluru) 2. Indian Medical Device Regulations - Streamlined for Focused Research Ms. Mala Srivastava (Nextvel Consulting, Bengaluru) 3. Medical Device Trials-Investigator s Perspective Professor (Dr) Suman Rao (St. John s, Bengaluru) :30 Conference Closing Programme, Recognitions and Prize distributions

20 th -21 st July, 2017 All India Institute of Medical Sciences, Rishikesh (Uttarakhand)

Basic Surgical Skills Course & Workshop on SOTM & SOE 20 th -21 st July, 2017 All India Institute of Medical Sciences, Rishikesh (Uttarakhand) Organized by: Department of Surgery, AIIMS Rishikesh Supported