I NTER S YSTEM B IOMEDICA E THICS C OMMITTEE Established in 2008 Registered with GOI - 2008 Accredited to DCGI - 2013 WEBSITE : www.isbec.india.org Established.

Slides:

Advertisements

Similar presentations

Research Governance Where Does Ethical Review Fit?

Advertisements

Vilnius, 29 June 2007 CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research Gottfried Kreutz Dr. med., Dipl.-Chem.;

Ethics review and oversight for better governance of health research Amar Jesani Indian Journal of Medical Ethics Centre for Studies in Ethics and Rights.

Terry Fulmer, PhD, RN, FAAN The Erline Perkins McGriff Professor & Head, Division of Nursing New York University Steinhardt School of Education 246 Greene.

Date: Saturday, April 28, 2007 Presented by: Carl C. Booberg Executive Director of the American Thoracic Society.

CDM EB Experience and lessons for JI Mr. LU Xuedu March 8-9, 2006 Bonn, Germany.

Graduate Research Degree Orientation 2013 Decision Making and Governance.

Establishment of an Intersystem Ethics Committee & Capacity Building of EC members & of applicants Intersystem Biomedica Ethics Committee, Mumbai Dr Jayashree.

1 SAPA-GP Webinar Program A Professional Training Tool for SAPA Members Non-members are Welcome to Participate SAPA-GP Webinar Program A Professional Training.

Asia Consortium Regional chapter in Asia ISPOR-INDIA Chapter Jawahar Bapna PhD, MD, MBBS Adjunct Professor, Pharmaceutical Management Institute of Health.

Vice-rector of research department A.S. Karakushikova Director of Research and Education activities of Academic and Research Institution of Fundamental.

Board of Directors Open Meeting2010 Board of Directors Open Meeting 2010 Asia Consortium Regional chapter in Asia Anita Kotwani PhD on behalf of ISPOR-INDIA.

Clinical Trials of Traditional Herbal Medicines In India Y.K.Gupta Professor & Head, Department of Pharmacology, All India Institute of Medical Sciences,

Public, Private & Faith-based Partnerships in Papua New Guinea How to provide innovative, needs-based programs to support HIV health care capacity building.

Padmashree Prof.(Dr.) N.R. Madhava Menon Living Legend of Law.

Department of AYUSH Ministry of Health and Family Welfare Government of India Directorate of Indian Systems of Medicine Government of Jammu & Kashmir.

Vikram G, DHI 4 th Environmentally Friendly Vehicles Conference Presentation by Mr. Vikram Gulati, Director Department of Heavy Industry, Government of.

Emergency Medicine in Jordan Rashed Hijazi MD, FRCSEd (A&E) Consultant EM.

The Medical Tourism The Meditour

Why companies saying or should say “YES” to India for Studies.

Professional Guidelines for Stem Cell Translation ISSCR George Q. Daley Director, Stem Cell Transplantation Center Children’s Hospital/ Harvard Medical.

Traditional & Complementary Medicine in Malaysia [International Conclave on Traditional Medicine, New Delhi, INDIA Nov. 2006] Datuk Dr. M.S. Pillay.

Clinical Research Training

Target Institute of Medical Education & Research (TIMER) Provides Clinical Research services to Pharmaceutical, Biotechnology product companies right.

Advisory Director – Clinical research & Business development Senior Clinical research and Business development professional with 10+ years of experience.

The South African perspective

Clinical Research in South Africa - Ethical and Regulatory Processes NATIONAL HEALTH RESEARCH ETHICS COUNCIL Professor A Dhai Deputy Chair National Health.

About HKOES The Hong Kong Optical Engineering Society (HKOES), formerly the Hong Kong Chapter of the SPIE was launched on the 11th of April 2008 as a new,

ISPOR POLAND CHAPTER Polish Society of Pharmacoeconomics (PTFe )

September 19, 2015 Timings: am to pm Venue: ICAP House, Seminar Room, Thokar Niaz Baig, Lahore CHARATERED ACCOUNTANT STUDENT ASSOCIATION NORTH.

ETHICS IN MEDICAL RESEARCH IN MYANMAR

Tony, Yen-Huei Tarn, M.S., Ph.D. President, TaSPOR Introduction of Taiwan Society for Pharmacoeconomics and Outcomes Research (TaSPOR) ISPOR 2ND ASIA-PACIFIC.

Announce Strategic Partnership! 16 th July 2015.

Narsee Monjee Institute of Management Studies (Deemed University ) Global Standards and Certification of Management Consultants Aneeta Madhok President.

Regulatory Mechanism in Clinical Trials Convention Hall, SIU Lavale.

Jean Nestor Project manager: Regulation 26th November 2005 The Prince of Wales’s Foundation for Integrated Health.

TRADITIONAL MEDICINE LANDSCAPE IN SOUTH AFRICA

Implementing the GRADE Method in Guideline Development: Real- World Experiences Contemplation Stage: To GRADE or Not to GRADE? Sheila A. Agyeman, MHA Director.

Progress Report of Taiwan Society for Pharmacoeconomics and Outcomes Research (TaSPOR) ISPOR 15th Annual International Meeting Hilton Atlanta, Atlanta.

National Coalition for Sustained Iodine Intake (NCSII)

1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 1 Prevention Research and National AIDS Plans June 2005 Geneva, Switzerland Prof. Roy.

Lilly Answers that Matter. Preserving the Value of Industry Interactions with Health Care Professionals Jack Harris, M.D. Vice President, U.S. Medical.

Beyond Regulations: Ethical Considerations in Research

Dr. Samuel Dyer - Chairman of the Board - Medical Science Liaison Society MSL What is a Medical Science Liaison? (What Do.

IRB – Investigator/Research Coordinators Monthly Meeting Gerald D. Fischbach, M.D. Executive Vice President for Health and Biomedical Sciences and Dean.

HCPC Registration for Biomedical Scientists

Global standards for midwifery regulation Midwifery Gap analysis Workshop, Nairobi/Kenya May 2015 Martha Bokosi, Project.

‘One lay person from the community should be on Ethics committee (EC) to represent the differed points of view’ - ICMR 2006, Schedule Y 2005 The Community.

PRESENTED BY : (AECCI )ASIAN EXPORTERS’ CHAMBER OF COMMERCE AND INDUSTRY CBD BELAPUR, NAVI MUMBAI Date: PRESENTED BY : (AECCI )ASIAN EXPORTERS’

Revision of 4 th edition standards Dr S Murali MD DM Chairman Technical Committee NABH Consultant Neurologist & Chief Clinical Services Manipal Hospital.

GCP Guidelines for ASU drugs- Issues & Solutions

CAHO Dr. Alexander Thomas President, CAHO. Origin of CAHO All stakeholders keenly felt the need for a platform for accredited hospitals and laboratories.

FORSEWA (FORMER SPIC EMPLOYEES WELFARE ASSOCIATION)

29052-PorterJ32.ppt Roger J. Porter, M.D. Consultant Adjunct Professor of Pharmacology, USUHS Adjunct Professor of Neurology, Univ. of Pennsylvania Former.

CAHO Dr. Alexander Thomas President, CAHO.

Quality Council of India The National Accreditation Structure

Symposium on Chemical Biology And Drug Discovery (SCBDD-2017) &

Paya Serai Coffee House

EAST AFRICAN COMMUNITY MEDICINES REGULATORY HARMONIZATION (EAC-MRH) PROJECT PROGRESS NAIROB I - KENYA By: EAC - Secretariat.

RESEARCH SERVICE AND INFORMATION FOR THE NATIONAL ASSEMBLY OF VIETNAM

Bangladesh Accreditation Board (BAB)

Conference Series LLC Conferences

Delegate Registration Form

K K Aggarwal MBBS, MD Recipient of Padma Shri, Vishwa Hindi Samman, National Science Communication Award and Dr B C Roy National Award Gold.

Annual report of the Secretary general

\TæiBl nigviTüasaRsþénsarFatuGaCI(ARGI+)

K K Aggarwal MBBS, MD Recipient of Padma Shri, Vishwa Hindi Samman, National Science Communication Award and Dr B C Roy National Award Gold.

Trial Funding and Engagement: The NIH Sponsored CTSA Program

Patient information sheet & Principles of Good Clinical Practice

JAMAL MOHAMED COLLEGE (AUTONOMOUS) College with Potential for Excellence Re-accredited (3 rd cycle) with ‘A’ Grade by NAAC Affiliated to Bharathidasan.

Presentation transcript:

I NTER S YSTEM B IOMEDICA E THICS C OMMITTEE Established in 2008 Registered with GOI Accredited to DCGI WEBSITE : Established in 2008 Registered with GOI Accredited to DCGI WEBSITE :

INTRODUCTION  ISBEC is the first independent Ethics Committee to have multisystem experts  ISBEC has a panel of experts from all systems of medicine, basic sciences, social scientists, lay person representation and legal experts  ISBEC was formed as a result of the efforts of two giants in Clinical Pharmacology in India, Dr Arun Sangani and Dr Ashok Vaidya, both pioneers in Clinical Trials in India  ISBEC is the first independent Ethics Committee to have multisystem experts  ISBEC has a panel of experts from all systems of medicine, basic sciences, social scientists, lay person representation and legal experts  ISBEC was formed as a result of the efforts of two giants in Clinical Pharmacology in India, Dr Arun Sangani and Dr Ashok Vaidya, both pioneers in Clinical Trials in India

Current Status  Under the Chairmanship of Dr Kiran Marthak, Inter System Biomedica Ethics Committee (ISBEC) is registered with Drug Controller General India for approval of BA/BE studies  (Registration No. CR/108/Indt/MH/2013)  Dr Kiran Marthak is an eminent Physician, Clinical Pharmacologist and Pharmaceutics expert with multinational experience  Under the Chairmanship of Dr Kiran Marthak, Inter System Biomedica Ethics Committee (ISBEC) is registered with Drug Controller General India for approval of BA/BE studies  (Registration No. CR/108/Indt/MH/2013)  Dr Kiran Marthak is an eminent Physician, Clinical Pharmacologist and Pharmaceutics expert with multinational experience

ALLOPATHY UNANI HOMEOPATHY YOGA NUTRITION YOGA NUTRITION AYURVED SIDDHA ISBEC

Composition of ISBEC Sr. No Members Name & AddressCapacity 1Dr Kiran Marthak, MD, F.F.P.M. - D.B.M. Board member and Global Head of Clinical Development at Lambda Therapeutics Research Ltd, located at Ahmedabad and Mumbai. Member- Chairman Physician, Clincal Pharmacologist and Pharmaceutical expert 2Dr. Meena Dave M. D., M.B.B.S., Res: 703, Varun, 1054 J.P. Road, Versova, Mumbai Tel. No- (R) Mobile E. mail: Member Clinical Pharmacologist 3Dr. Deepak Dave M.D, D.G.O Former Vice-President of FOGSI Former President Rotary Club, Juhu, Mumbai Medical Director, Kasturba Health Society Res : Reyn Basera, 24, Vallabh Nagar, Juhu Scheme, Vile Parle (W), Mumbai Tel: (O) / Tel : (R) / Mobile : E. mail : Vice- Chairperson Cons. Obst/ Gynaecologist 4Dr. Vanlila Mehta M. B. B. S, D. G. O, DRCOG, Pharmaceutical Consultant, Former Medical Director, 44, Udadhi Tarang Co. op. Soc, Juhu, Mumbai Tel: / Mobile: E. mail: Member- Secretary - Clinical Pharmacologist 5Dr. Jayashree Joshi MD, Ph.D, Cons. Reproductive Medicine, (Former Deputy Director, NIRRH- ICMR), Jt Research Director, Kasturba Health Society, Tel (O): / Residence-Dr Jayashree Joshi, 503, Om-Shiv Housing Society, Plot No 277,, Mahim, Mumbai – Tel: ® ; Mobile: E. mail: Member- Secretary Cons. Obst/ Gynaec 6Dr. Ashok D. B. Vaidya MD, Ph.D, Former Research Director, CIBA & WHO Consultant, Recipient of Several Awards, Former Med & Res. Director- Bhavan’s SPARC, Research Director, Kasturba Health Society, Res: 501 Tanisha, L.S.Raheja Marg, 9 th,11 th cross road, Khar West, Mumbai Tel: / Tel No: ®, Mobile : E. mail : Member Cons. Pharmacologist 7Dr. Rama Vaidya MD, Ph. D, Former Deputy Director, NIRRH, ICMR, Recipient of Several orations, Dean, Kasturba Health Society, Res:501 Tanisha, L.S.Raheja Marg, 9 th,11 th cross road, Khar West, Mumbai Tel: / Tel No: ®,Mobile : E. mail : Member Cons. Obst / Gynaec 8Mrs. Neeru Kamlesh Mehta, Flat No. 301/302, 3 rd Floor, Res: Mumbai Tel No: E. mail : Member/ Lay Person 9Dr. Pradnya Talawadaker,BAMS, LLM, Res: 2 nd Flr. Trimurti, Kalanagar,Bandra (East), Mumbai-51. Mobile E. mail: Member / Legal Expert 10.Dr. Mrunal Marathe M.Sc(Psychology)Ph.D(H.S.S) Add-37,Mitra Milan, Sion HSG Society, Scheme 6, Road 2, Sion (e), Mumbai Tel:(022) Tel:(022) Mob: Member/ Social Scientist LIST OF ALTERNATE MEMBERS 1Mr. Sharad D. Chitnis B.A., L.L.M., Chitnis Vaithy & Co. Advocate & Solicitors, 410/ 11, Gundecha Chambers,, Fort, Mumbai Tel. No /15 Mobile E. mail : Member/Legal Expert 2Mrs. Manisha B Naikdalal M.Com 12,Sneha,D.S.Babrekar Marg, Dadar,Mumbai Tel: Mob: Member/ Layperson 3Dr. Helen Joseph MSW,Ph.D B-503 Bhakti Complex, Link Road Ext, Dahisar(W), Mumbai Tel: Mob: Member/ Social Scientist 4Dr. Daniel Joseph MD(Pharmacology) Address: 106, ’B’,Nibbana,Pali Hill Road, Bandra(W), Mumbai Tel No: (022) Member/Clinical Pharmacologist 5. Mr Bharat Joshi BSc LLM Address: 24/44/48, Darshaw Bldg, 24, Jambulwadi, Kalbadevi Rd, Mumbai , India. Telephone No: Telefax: Member/Legal Expert

Composition of ISBEC

(Alternate members) Composition of ISBEC (Alternate members)

Objectives  Function as an independent ethics committee for encouraging scientific progress of various systems of medicine  Formulate guidelines for research in inter system research  Guide the industry in conducting in clinical trials as per ICH guidelines  Undertake training in Research Ethics in clinical medicine  Collaborate with the ICMR, CSIR, AYUSH, CCRAS  Function as an independent ethics committee for encouraging scientific progress of various systems of medicine  Formulate guidelines for research in inter system research  Guide the industry in conducting in clinical trials as per ICH guidelines  Undertake training in Research Ethics in clinical medicine  Collaborate with the ICMR, CSIR, AYUSH, CCRAS

Achievements 9

Publications  Proceedings of ICMR Seminar on “Ethics in Intersystem Biomedical Research- Problems, Challenges, Guidelines, Organised by ISBEC ”, at Bhavan’s SPARC, Mumbai, 23rd January, 2005  Joshi JV, Dave DD. Designing Clinical Trials Clinical Trials in pregnant & nursing women: Points to ponder! In: Regulatory Requirements for Drug Development & Clinical Research. 1st Edition, Edited by Kshirsagar NA, Published by Indian Council of Medical Research, Chapter 16 ; pp (2013)  Proceedings of ICMR Seminar on “Ethics in Intersystem Biomedical Research- Problems, Challenges, Guidelines, Organised by ISBEC ”, at Bhavan’s SPARC, Mumbai, 23rd January, 2005  Joshi JV, Dave DD. Designing Clinical Trials Clinical Trials in pregnant & nursing women: Points to ponder! In: Regulatory Requirements for Drug Development & Clinical Research. 1st Edition, Edited by Kshirsagar NA, Published by Indian Council of Medical Research, Chapter 16 ; pp (2013)