Program Brochure ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH

Program Brochure National Training Program on Good Clinical Practice Current regulatory and ethical requirements for conducting clinical trials/research in India October 03-04, 2018 ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH All India Institute of Medical Sciences (AIIMS) Rishikesh is one of SIX NEW AIIMS established by Ministry of Health & Family Welfare, Government of India under Pradhan Mantri Swasthya Suraksha Yojna (PMSSY) with aim of correcting regional imbalances in quality tertiary level healthcare in country and attaining selfsufficiency in graduate and postgraduate medical education. AIIMS, Rishikesh was established by an Act of Parliament with main mission being establishment of a center of excellence in medical education, training, health care and research imbued with scientific culture, compassion for sick and commitment to serve under served. www. http://aiimsrishikesh.edu.in Clinical Development Service Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute, an autonomous institute of Department of Biotechnology, Ministry of Science & Technology, Government of India. It has been established to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.www.cdsaindia.in and CDSA have joined hands for capacity and capability building by conducting GCP Workshop at.

Good Clinical Practice (GCP) is an international ethical and quality standard for design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, that provides assurance that Rights, safety and well-being of human research participants are well protected Data and reported results are credible and accurate Learning Objectives: To seek cognizance towards principles of GCP, roles and responsibilities of various stakeholder involved in a clinical research/trial To understand current ethical and regulatory requirements for conducting clinical research/trial in India To be aware of national ethical guidelines for biomedical and health research involving human participants by ICMR and national ethical guidelines for biomedical research involving children by ICMR To understand various requirements for seeking accreditation/registration of ethics committees To enable participants to understand that by seeking compliance to GCP they can give public an assurance that rights, safety and well-being of human participants are well protected and data from study results are credible and accurate Who can attend? Practicing clinicians, Faculty members, Senior Residents and PG from Medical/ Dental Institution Research scholars in Biomedical Sciences, Pharmaceutical Sciences and Pharmacy Practice Hospital/Health care administrators Faculty from Indigenous system of medicine, personnel like CRCs, Monitors, Auditors, etc. Industry/Institution/Academia Number of participants: One Hundred Fifty [150] Fees: Registration Till 30 Sept 2018 After 30 Sept 2018/ Spot Students & Residents (JR & SR), PhD 1500 INR 2000 INR Faculty & Others 2000 INR 3000 INR NEFT/RTGS details for online transaction: Bank : Punjab National Bank Branch : Barrage Construction City : Rishikesh (Uttarakhand) IFSC Code : PUNB0618900 MICR Code : 249024155 Account Name : Medical Education Account Number : 6189000100043376 How to register? Kindly send scanned copies of NEFT receipt & duly filled registration form to email: gcp.aiimsrish@gmail.com CME credit hours: All medical professionals (MBBS and above) will be granted 04 CME credit hours from Uttarakhand Medical Council. How to reach us? Workshop Secretariat: HOD Microbiology Office, Department of Microbiology, 3 nd Floor, Medical College Block, AIIMS, Rishikesh gcp.aiimsrish@gmail.com (Do write to us for workshop related queries.)

Organizing Committee Chief Patron Prof. Ravi Kant Director & CEO Patron Prof. Surekha Kishore Dean (Academic) Organizing Chairperson Prof. Pratima Gupta Dean (Research) Organizing Secretary Prof. Shalinee Rao Vice Dean (Research) Knowledge Partner Clinical Development Services Agency (CDSA) Organizing Co-Secretary(ies) Dr. Manisha Naithani Sub Dean (Research) Dr. Puneet Dhamija Department of Pharmacology Treasurer Dr. Rajesh Kathrotia Department of Medical Education Registration & Execution committee Ms Diksha, Dr. Manisha Paul, Dr. Himanshu Narula, Dr. Ranjana Rohilla, Dr. Swati, Dr. Parmila Dudi, Dr..Rabari Kamlesh

All India Institute of Medical Sciences (AIIMS), Rishikesh Good Clinical Practice Current regulatory and ethical requirements for conducting clinical trials / research in India including Schedule Y October 03-04, 2018 Venue: LT-4, 4 th Floor, College Building Program Agenda October 03, 2018 (Day 01) Time Title (Learning Objectives) Presenter 08:30 09:00 Registration & Ice breaker Vandana Chawla Manager Training, CDSA, THSTI, DBT Team 09:00 09:30 Welcome Address Course Introduction & Overview Vote of Thanks 09:30 10:00 Group Photograph & Networking Tea 10:00 10:45 10:45 11:30 11:30 12:15 12:15 13:00 Overview of GCP What is GCP? Why GCP? Principles of GCP GCP (CDSCO, ICH GCP R2) Current regulatory requirements for conducting clinical trials/research in India (including Schedule Y) Current ethical requirements for conducting clinical trials/research in India National ethical guidelines 2017 13:00 13:45 Lunch 13:45 14:15 14:15 14:45 Roles and Responsibilities of Investigator and Monitor Ethics Committees Accreditation & Recognition: NABH; SIDCER 14:45 15:15 Record Keeping and Data Handling Prof. Ravi Kant Director and CEO, All India Institute of Medical Sciences (AIIMS), Rishikesh Dr. Pratima Gupta Dean (Research), Professor & Head of Microbiology, AIIMS, Rishikesh Shri. A. B. Ramteke Former Joint Drugs Controller (India), CDSCO, HQ, New Delhi; Consultant, Regulatory Affairs, CDSA Dr. Nandini K. Kumar Former Deputy Director General (Senior Grade), ICMR; Adjunct Faculty, CDSA, THSTI, DBT Dr. Nandini K. Kumar Former Deputy Director General (Senior Grade), ICMR; Adjunct Faculty, CDSA, THSTI, DBT Dr. Monika Bahl Director Clinical Portfolio Management, CDSA, THSTI, DBT Dr. Monika Bahl Director Clinical Portfolio Management, CDSA, THSTI, DBT 15:15 15:30 Tea/Coffee Break 15:30 17:00 Exercises, Case studies, Group activities Dr. Monika Bahl; Dr. Nandini K. Kumar; Shri. A. B. Ramteke; Dr. Sucheta Banerjee Kurundkar; Dr. Seema Pai >17:00 Open Forum for Q & A

All India Institute of Medical Sciences, Rishikesh Good Clinical Practice (3-4 October 2018) Registration Form Name: Designation: Institute/Official Address: Email : Phone no. Transaction no. & Date: Registration Fees Category Till 30 September 2018 Faculty/Administrator Rs 2000 Rs 3000 SR/PG/PhD Scholar (Medical/Dental/Nursing) Rs 1500 Rs 2000 Tutors/Interns/ Paramedical staff Rs 1500 Rs 2000 After 30 September 2018 Account Details : Bank : Punjab National Bank A/C Name - Medical Education, A/c No.- 6189000100043376, lfsc code - PUNB0618900 Registration fees can also be paid directly by Debit/Credit/ATM card through swipe machine available in Department of Medical Education,. For Registration Contact: Prof. Pratima Gupta, Organising Chairperson Mobile: +91 8475000272 Email: gcp.aiimsrish@gmail.com Only digital transaction is permitted Kindly send scanned copy of filled-in registration form with transaction details to above email ID for registration. Signature of Participant