HRPP Manual at TMC Recognitions IRB Staff Mandate Terms of Reference Responsibility institution Meeting Schedule Composition IEC-I IEC- II IEC- III FAQs-ver1.0 SOPs IEC- Forms
The IEC is established to formalize and specify Institution's commitment to the promotion of high scientific and ethical standards in patient care, professional education, clinical research, and community interests.
Timely review and the safeguarding of high ethical standards formed the basis of the IRB review process. These are essential for clinical research including student research, investigator initiated research, extramural, intramural funded research and multi-centric multinational research.
Institutional Review Boards (IRBs) became functional in February 2012. TMC-ACTREC Institutional Ethics Committee (IEC III) was established in December 2009.
As per DCGI registration dated May 2013, Institutional Review Boards (IRBs) are renamed as Institutional Ethics Committees (IEC-I,II,III). Institutional Ethics Committees function with the same purpose and SOPs.
The Institutional Ethics Committees (IECs) are constituted by the Director, Tata Memorial Centre (TMC) under authority vested by the Governing Council of the TMC.
The Data Safety Monitoring Subcommittee (DSMSC) is a subcommittee of the IEC, and is essentially responsible for monitoring patient safety and assessing data during the course of the study in a manner that contributes to the scientific and ethical integrity of the study.
DCGI Registration under Rule 122DD of the Drugs & Cosmetic Rules 1945.
IEC has a Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS) through the Office for Human Research Protections (OHRP). The assurance number is FWA00006143. This is periodically renewed as required. IEC is also registered with HHS and has IORG Nos. IRB00003414 & IRB00007802 for IEC-I & IEC-II respectively. This is periodically renewed as required.
WHO/The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) WHO/The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in collaboration with the Forum for Ethical Review Committees in Asia and the Western Pacific Region Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) has awarded recognition to the Tata Memorial Centre Human Ethics Committee (TMC-HEC) in November 2009. The recognition of IRB was renewed in Nov 2012. |
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The IEC through its delegated sub-committees functions independently for maintaining a consistent scientific and ethical framework for patient care and research, and for integrating ethical values into practice, policy relationships, and organizational activities. |
The purpose of the IEC is to cultivate a pluralistic and democratic exchange of scientific and ethical values and concerns, and to critically analyze them while looking for opportunities to enhance the scientific and ethical integrity of Institution. |
The mandate of the IEC essentially is to promote patient care through a scientific and ethical approach to research and education. |
1 |
Ensure the highest scientific and ethical standards of research at TMC |
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Review and approve, proposals for clinical, basic or translational research projects (Intra and Extra mural) for scientific and ethical content |
3 |
Improve ethical standards and issue guidelines on ethical dilemmas related to patient care services |
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To function as a forum to advise the administration in case of any ethical issues that may arise from patients, families or public |
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To maintain our leadership as a national standard of reference in all fields |
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To issue and periodically, update and revise SOP s and guidelines for effective functioning of IEC as and when necessary |
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Continuing education in clinical research bioethics and ethical aspects of clinical practice by seminars, workshops and interactive discussions for all categories of staff members including nursing and paramedical staff |
8 |
To initiate and commission research studies on ethical aspects of practice in TMC |
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IEC- I fourth Tuesday of every month at 8.30 a.m. (unless otherwise notified) |
IEC- II second Wednesday of every month at 8.30 a.m. (unless otherwise notified) |
The IEC-III meets on Third Friday of every month at 9.30 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC IEC processing fees (applicable for all pharmaceutical sponsored studies)
The fees will be accepted as cheque/demand draft drawn in favour of “Tata Memorial Centre". |
Each IEC will be multidisciplinary and multi-sectorial in composition. Each IEC is composed of a minimum of 7, and maximum of 15 members. The members are selected so as to have an equitable representation of all specialties in TMC. It includes scientific and non-scientific members, clinicians and non - clinicians, a clinical pharmacologist, members of the community, a lawyer-expert in ethics, a social worker / layperson / patient representative to represent different points of view. |
Each committee will comprise of a Chairperson, Co-Chairperson, a Member Secretary, and 4-12 other active members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community interests.
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The committee should have adequate representation of age, gender, community, etc. to safeguard the interests and welfare of all sections of the community / society. Members are expected to be aware of local, social and cultural norms, as this is the most important social control mechanism.
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The members should have various backgrounds to promote complete and adequate review of research activities commonly conducted by TMC. |
Sr. No. |
Name |
Position |
Affiliation |
Affiliation Status |
Gender |
Expertise |
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1.
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Dr. Nithya Gogtay | Chairperson | Professor, Dept of Clinical Pharmacology, KEM Hospital | Non Affiliated |
Female
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Basic Medical Scientist (Clinical Pharmacologist)
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2.
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Dr. Sangeeta Mudaliar
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Co-Chairperson | Full Time Consultant & Head of The Department, Paediatric Hemato-Oncology B J Wadia Hospital |
Non Affiliated
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Female
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Medical Oncologist (Pediatrician)
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3.
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Dr. Gouri Pantvaidya | Member Secretary | Professor, Department of Surgical Oncology, Tata Medorial Hospital | Affiliated |
Female
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Surgeon
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4.
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Mr. KV Ganpathy | Member | CEO, Jeet Association for Support to Cancer Patients (JASCAP) | Non Affiliated |
Male
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Lay Person
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5.
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Dr. Mrunal Marathe |
Member | Freelance Counselor and Trainer associated with NGO-St.Jude’s- Childcare Centre and Adoption Group, Asha Sadan Orphanage | Non Affiliated |
Female
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Social scientist |
6.
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Mr. N. D. Jay want | Member |
Advocate, High court, Mumbai |
Non Affiliated |
Male
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Legal expert
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7.
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Dr. Sachin Satpute | Member |
Asst. Professor, Dept. of Pharmacology, Topiwala National Medical College & BYL Nair Ch. Hospital |
Non Affiliated |
Male
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Basic Medical Scientist (Clinical Pharmacologist) |
8.
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Dr. Bharatsinha Bhosale |
Member |
Senior consultant Oncologist, Bombay Hospital Medical and Research Institute Visiting Consultant Oncologist Jaslok Hospital Medical & Research Institute, SL Raheja Fortis group of Hospital |
Non Affiliated |
Male
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Medical Oncologist
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9.
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Dr. Maya Prasad | Member & Secretary, Data Safety Monitoring Unit (DSMU) |
Associate Professor, Dept. of Medical (Paediatric) Oncology, Tata Memorial Hospital |
Affiliated
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Female
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Medical Oncologist
( Pediatrician) |
10.
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Dr. Santosh Menon | Member |
Professor, Dept. of Pathology,Tata Memorial Hospital |
Affiliated
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Male
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Basic Medical Scientist (Pathologist)
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11.
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Dr. Prakash Nayak |
Member | Associate Professor, Dept. of Surgical Oncology, Tata Memorial Centre |
Affiliated
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Male
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Surgeon
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12.
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Dr. Jeson Doctor | Member | Associate Professor, Dept. of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital |
Affiliated
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Male
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Anesthesiologist
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13.
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Dr. Sabita Jiwnani | Member |
Associate Professor, Dept. of Surgical Oncology, TMH |
Affiliated
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Female
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Surgeon
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14.
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Dr. Tabassum Wadasadawala | Member |
Associate Professor, Dept. of Radiation Oncology, TMH |
Affiliated
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Female
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Radiation Oncologist
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The IEC-I fourth Tuesday of every month at 8.30 a.m. (unless otherwise notified) in the IRB Meeting Room, 3rd Floor, Main Bldg., TMH. The Member Secretary of IECs and DSMU will be Members of TRAC.
Sr. No. |
Name |
Position |
Affiliation |
Affiliation Status |
Gender |
Expertise |
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1.
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Dr. Shyam Kishore Shrivastava | Chairperson | Director, Radiation Oncology, Apollo Hospitall | Non Affiliated |
Male
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Radiation Oncologist |
2.
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Dr. Sudeep Shah | Co-Chairperson | Consultant, Surgical Gastroenterology, Hinduja Hospital | Non Affiliated |
Male
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Surgeon |
3.
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Dr.Priya Ranganathan |
Member Secretary |
Professor, Dept. of Anaesthesia, Tata Memorial Hospital |
Affiliated
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Female
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Anesthetist
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4.
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Dr. Padmaja Marathe | Member | Prof. (Additional) Dept of Pharmacology and Therapeutics, Seth G S Medical College and KEM Hospital, Mumbai | Non Affiliated |
Female
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Clinical Pharmacologist
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5.
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Mrs. Manisha Naikdalal | Member | Member of Ethics Committees at Hinduja Hospital (IEC-1),IITB,Global Hospital, Nair Hospital ISBEC (InterSystems Biomedica Ethics Committee) , Altemate Member (Layperson) at and KEM Hospital and Lilavati Hospital | Non Affiliated |
Female
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Lay Person
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6.
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Dr. Bindulakshmi P | Member | Associate Professor, Advanced Centre for Women’s Studies, School of Development Studies, Tata Institute of Social Sciences | Non Affiliated |
Female
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Social scientist |
7.
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Mr. Agnel Cameiro | Member | Advocate Associate, Mulla & Mulla & Craigie Blunt & Caroe, Mulla House, 51 Mahatma Gandhi Road, Fort, Mumbai 400 001. | Non Affiliated |
Male
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Legal expert
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8.
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Dr. Gaurav Narula | Member | Professor, Dept. of Medical Oncology ( Pediatric), TMH |
Affiliated
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Male
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Medical Oncologist
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9.
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Dr. Nehal Khanna | Member | Associate Professor, Dept. of Radiation Oncology, TMH |
Affiliated
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Female
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Radiation Oncologist
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10.
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Dr.Shivakumar Thiagarajan |
Member |
Associate Professor, Head and Neck Oncology, Tata Memorial Hospital |
Affiliated
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Male
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Surgeon
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11.
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Dr. Nita Nair |
Member |
Professor, Surgical Oncology ( Breast Service ), TMH |
Affiliated
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Female
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Surgeon
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12.
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Dr. Nilesh Lokeshwar | Member | Consultant, Asian Cancer Institute, Sion (E), Mumbai | Non Affiliated |
Male
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Medical Oncologist
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13.
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Dr. Sewanti Limaye | Member | Consultant, Medical Oncology, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai | Non Affiliated |
Female
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Medical Oncologist
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14.
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Dr. Munita Bal |
Member |
Professor, Dept. of Pathology, TMH |
Affiliated
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Female
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Basic Medical Scientist (Pathologist)
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15.
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Dr. Nilendu Purandare | Member |
Professor, Dept. of Nuclear Medicine, TMH |
Affiliated
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Male
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Radiologist
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The IEC-II second Wednesday of every month at 8.30 a.m. (unless otherwise notified) in the IEC Meeting Room, 3rd Floor, Main Bldg., TMH. The Member Secretary of IECs and DSMU will be Members of TRAC.
Sr. No. |
Name |
Position |
Affiliation |
Gender |
Expertise |
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1.
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Dr. Surekha Zingde |
Chairperson
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Trustee, Indian Women Scientists' Association (IWSA), Former Deputy Director, CRI, Scientific Officer ‘H’ |
Female
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Basic Scientist
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2.
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Dr. Siby K. George |
Co- Chairperson
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Professor of Philosophy, Department of Humanities & Social Sciences, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, India |
Male
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Philosopher
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3.
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Dr Sudhir Nair |
Member Secretary
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Prof. Head and Neck Surgical Oncology, ACTREC., TMC |
Male
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Clinician (Surgical oncology) |
4.
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Dr. Pramila Yadav |
Member
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Prof, Dept of Pharmacology, Dr D Y Patil Medical college, Nerul, Navi Mumbai |
Female
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Clinical Pharmacologist |
5.
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Mrs. Deepa Ramani |
Member
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Ex-play group teacher, store and purchase in-charge, Zenith Spinners Ltd. Member of IC-SCR, ACTREC |
Female
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Layperson
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6.
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Mr Akil Hirani |
Member
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Head of the Transactions Practice and Managing Partner Majmudar & Partners, International Lawyers, India |
Male
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Legal Expert |
7.
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Dr. Punit Jain |
Member
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Consultant Hematologist/ Hemato-Oncologist & Bone Marrow Transplant Physician, Apollo Hospitals, Belapur, Navi Mumbai Member of IC-SCR, ACTREC |
Male
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Clinician (Medical Oncology) |
8.
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Dr Uma Dangi |
Member
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Consultant Medical Oncology Fortis Hospital, Mulund, Vashi and Kalyan |
Female
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Clinician (Medical Oncology)
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9.
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Dr. Tanuja Teni |
Member
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Principal Investigator and Scientific Officer ‘G’ ACTREC, TMC |
Female
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Basic Scientist
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10.
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Dr Naveen Mummadi |
Member
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Asst. Professor, Dept. of Radiation Oncology, ACTREC, TMC |
Male
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Clinician (Radiation Oncology)
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11.
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Dr. Reshma Ambulkar |
Member and DSMU Secretary
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Professor, Dept. of Anaesthesia, Critical Care and Pain, ACTREC, TMC.. |
Female
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Clinician
(Anaesthetist and Intensivist) |
12.
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Dr. Shalaka Joshi |
Member
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Associate Professor, Dept. of Surgery, Tata Memorial Hospital, TMC. |
Female
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Clinician (Surgical oncology)
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13.
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Dr. Bhausaheb Bagal |
Member
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Professor and Consultant, , Dept. of Medical Oncology, Tata Memorial Hospital, TMC |
Male
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Clinician (Medical Oncology)
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14.
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Dr. Nitin S Shetty |
Member
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Prof. Interventional Radiology Tata Memorial Hospital, TMC |
Male
|
Clinician (Interventional Radiology)
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The IEC-III will meet on third Friday of every month at 10.00 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai. The Member Secretary of IEC -III will be Member of TRAC..
Link for TMC-IEC III (ACTREC IEC)
TATA MEMORIAL HOSPITAL
Dr. E Borges Road, Parel, Mumbai - 400 012 India
Phone: +91-22- 24177000, 24177300, 24161413
Fax: +91-22-24146937
E-mail : msoffice@tmc.gov.in(for patient care and queries)/cash@tmc.gov.in(for accounts related)/fundraising@tmc.gov.in (for donors and donation related)/registrar@tmc.gov.in(for education and training)/hrd@tmc.gov.in(for administrative - HRD matters)
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