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Topic
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Date
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Speaker
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Topic :
Training on rules and guidelines in Clinical research (NDCT 2019, ICH-GCP and ICMR guidelines)
[For Ethics Committee members, SAC members and Research staff]
Training organizers –
Dr Shweta A. Chitharanjan, Member Secretary, EC (CTR), DMHRC, Pune
Dr Amrita P. Prayag, Member Secretary, EC (BMHR), DMHRC, Pune |
6 October 2024 |
Patron, support and Director
Dr Dhananjay S. Kelkar
Speakers –
Preamble
Dr Amrita P. Prayag (DMHRC, Pune)
Trainer (s)
Dr Ravindra Ghooi (ERI, Pune) |
Training-cum-seminar program in guidelines and rules for clinical research
(For EC members, Research staff and Research consultants)
Organizers –
Dr Pethe V. (DMHRC, Pune) and Dr Ghooi R. (ERI, Pune)
Co-organizer –
Dr. Amrita P. Prayag (DMH, Pune) |
11 February 2024 |
Patron, support and Director
Dr. Dhananjay S. Kelkar
Meeting moderator –
Dr. Amrita P. Prayag
Speakers – (Topic) –
1. Dr Vaijayanti V. Pethe (Preamble)
2. Dr Nilesh Kurwale (ICH-GCP guidelines - R1 and R2)
3. Dr Ravindra Ghooi (New Drugs and CT Rules, 2019)
4. Dr. Aditi Apte (ICMR guidelines for biomedical and health research involving human participants)
Program logistics, registration and coordination –
- Dr. Shweta A. Chitharanjan
- RD_CRC team (Dr Deepali, Dr Tejashri, Mrs Shilpa, Mrs Varada)
|
Clinical research amid the ongoing permacrisis:
Training-cum-seminar program in guidelines, principles and rules for clinical research
Organizers –
Dr Pethe V. (DMH, Pune) and Dr Ghooi R. (ERI, Pune)
Co-organizer –
Dr. Amrita P. Prayag (DMH, Pune) |
20 November 2022 |
Patron, support and Director
Dr. Dhananjay S. Kelkar
Meeting moderator –
Dr. Amrita P. Prayag
Speakers – (Topic) –
1. Dr Vaijayanti V. Pethe (Preamble)
2. Dr Sameer Jog (ICH-GCP guidelines with clinical scenarios)
3. Dr Ravindra Ghooi (Rules and regulations in clinical research)
4. Dr Mohini Barde (ICMR guidelines for biomedical and health research involving human participants
5. Dr Sarita Mulkalwar (SAE reporting and causality analysis)
Speaker technical support –
Dr. Deepchand H. Agre
Co-ordination and logistics –
Dr Shweta Chitaranjan and RD CRC team -
Dr Deepali, Mrs Varada, Dr Tejashri and Mrs Shilpa
|
In-house research presentation meeting: A mixed bag theme of
Covid and non-Covid research during the past 2 years of the pandemic
Organizers –
Dr. Amrita P. Prayag and Dr. Vaijayanti V. Pethe
Speaker technical assistance - Dr. Deepchand H. Agre |
3 July 2022 |
Patron, support and Director
Dr. Dhananjay S. Kelkar
Meeting moderator – Dr. Amrita P. Prayag
Speakers – (Topic) –
1. Dr Vaijayanti V. Pethe (Preamble)
2. Dr Shilpa Kalane_(IHR 398 and IHR 432)
3. Dr. Shweta Panchakshari_(IHR 405 and 451)
4. Dr. Sachin Palnitkar_(IHR 402)
5. Dr Sumant Patil_(IHR 433)
6. Dr Yogesh Panchwagh_(IHR 453)
7. Dr Rahul Kulkarni_(IHR 372)
8. Dr Ashish Babhulkar_(IHR 412)
9. Dr Sonali Deshmukh_(IHR 421)
Meeting reminders and coffee co-ordination:
Dr Shweta A Chitharanjan |
|
Thesis Protocol Writing : Delivered a presentation to the new DNB trainees on the details of how a DNB Thesis Protocol is written in accordance with the guidelines by the National Board of Examinations. |
24 February 2022 |
Name of the speaker - Dr Amrita P. Prayag (In-charge, IHR regulation, RD)
|
Clinical research under the Covid cloud:
Training-cum-seminar program on guidelines and rules in research
Organizers –
Dr. Pethe V. (DMHRC, Pune) and Dr. Ghooi R. (ERI, Pune) |
14 November 2021 |
Patron, support and Director – Dr. Dhananjay S. Kelkar
Program moderator – Dr. Amrita P. Prayag
Speakers – (Topic) –
1. Dr Vaijayanti V. Pethe (Preamble)
2. Dr. Ravindra Ghooi, ERI, Pune
(New Drugs and CT Rules, 2019)
3. Dr. Aditi Apte, KEM Hospital and Research Center, Pune
(ICMR guidelines, 2017 and 2020)
4. Dr. Padmaj Kulkarni, DMHRC, Pune
(ICH-GCP guidelines with clinical scenarios- R1 and R2)
Program logistics, registration and coordination –
- Dr. Shweta A. Chitharanjan
- RD_CRC team (Dr Deepali, Dr Tejashree, Dr Smita, Ms Prerna, Mrs Tanuja, Ms Susmita and Mrs Shilpa ) |
In-house research promotion and productivity amid the ongoing pandemic:
overview of research pivoted to Covid
Organizers –
Dr. Amrita P. Prayag and Dr. Vaijayanti V. Pethe |
10 January 2021 |
Dr. Dhananjay S. Kelkar
In-house research policy in 2021
Program moderator – Dr. Amrita P. Prayag
Speakers – (Topic) –
1. Dr Vaijayanti V. Pethe (Preamble)
2. Dr Nilesh Mahale_(IHR 361)
3. Dr Girish Sarade_(IHR 370 and 388)
4. Dr Prashant Mishra_(IHR 374)
5. Dr Bharat Purandare_(IHR 375)
6. Dr Prasanna_(IHR 377)
7. Dr Rahul Kulkarni_(IHR 378)
8. Dr Gayatri Bhide_(IHR 382)
9. Dr Shirish Phansalkar_(IHR 383)
10. Dr. Sachin Gandhi_(IHR 385)
11. Dr. Arunkumar Tirlapur_(IHR 390)
12. Dr. Atul Mulay
Logistics and coordination–
Dr Shweta A. Chitharanjan |
Clinical research at an inflection point –
evolving to navigate the challenging times in the wake of the pandemic.
(Training-cum-seminar program on guidelines and rules in research)
Organizers –
Dr. Pethe V. (DMHRC, Pune) and Dr. Ghooi R. (ERI, Pune) |
29 November 2020 |
Patron, support and Director – Dr. Dhananjay S. Kelkar
Program moderator – Dr. Amrita P. Prayag
Speakers – (Topic) –
1. Dr. Vaijayanti V. Pethe (Preamble)
2. Dr. Ravindra Ghooi, ERI, Pune
(New Drugs and CT Rules, 2019)
3. Dr. Smita Tiwari, BJMC, Pune
(ICMR guidelines, 2017 and 2020)
4. Dr. Rahul Kulkarni, DMHRC, Pune
(ICH-GCP guidelines with clinical scenarios- R1 and R2)
Program logistics, registrations and coordination –
- Dr. Shweta A. Chitharanjan
- RD_CRC team (Drs - Deepali, Tejashree, Snehal, Smita, Asmita, Madhura, Kirtee)
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Hands-on workshop – Reference management using Mendeley reference manager for consultants in Radiology,
Cardiology, Pathology, Neurology, Gastroenterology, Oncology |
24 February 2020 |
Dr Gauri A. Oka (In Charge, In-house research) |
Training-cum-seminar program for consultants –
Capacity building in Clinical research methodology and manuscript writing
Organizers –
Dr Gauri A. Oka and Dr Vaijayanti V. Pethe |
9 February 2020 |
Patron, support and Director – Dr. Dhananjay S. Kelkar
Program moderator – Ms Devika Joshi
Speakers – (Topic) –
1. Dr. Vaijayanti V. Pethe – (Preamble)
2. Dr. Parikshit Gogate, MS, DNB, FRCS (Edin) (Ophthalm)
(Formulating a research question and Study designs -
Cross-sectional, case-control and cohort studies)
3. Mrs Vasumathi Sriganesh, BSc, MLib, CEO,
QMed Knowledge Foundation, Mumbai
(Literature search using PubMed)
4. Dr. Anita Kar, PhD, Former Professor and Director,
School of Health Sciences, SPPU
(IMRaD - what reviewers expect from each
section of the manuscript)
Program logistics, registrations and coordination –
RD_IHR team
Ms Aditi Deshpande
Ms Pooja Uchale
Ms Devika Joshi
|
Hands-on workshop – Reference management using Mendeley reference manager for consultants in ENT,
Ophthalmology, Obstetrics and Gynecology, Orthopedics, Surgery |
4 February 2020 |
Dr Gauri A. Oka (In Charge, In-house research) |
Hands-on workshop – Reference management using Mendeley reference manager for consultants
in Medicine, Anesthesia, Emergency Medicine, Pediatrics |
28 January 2020 |
Dr Gauri A. Oka (In Charge, In-house research) |
Awareness and training for EC(BMHR)
members as per the requirements of
New Drugs and CT Rules (2019), ICMR guidelines,
ICH-GCP and EC-2 SOP document |
4 November 2019 |
Constitution of EC(BMHR) as per the requirements of New Drugs and CT Rules (2019) – Dr Dhananjay S. Kelkar
Meeting Agenda –
Dr. Vaijayanti V. Pethe
Roundtable discussion –
Dr Pethe
Dr Amrita P. Prayag
Dr Shweta A. Chitharanjan
All members participated in the exchange.
|
Contemporary and emerging rules and guidelines in Clinical research
Organizers –
Dr. Pethe V. (DMHRC, Pune) and Dr Ghooi R. (ERI, Pune) |
15th September 2019 |
Patron, support and Director – Dr. Dhananjay S. Kelkar
Program moderator – Dr. Gauri A. Oka
Speakers (Topic) –
1. Dr. Vaijayanti V. Pethe (Preamble)
2. Dr. Ravindra Ghooi (New Drugs and CT Rules, 2019)
3. Dr. Ramesh Paranjape (ICMR guidelines)
4. Dr. Vaishali C. Deshmukh (ICH-GCP guidelines with clinical scenarios- R1 and R2)
Program logistics and coordination –
- Dr. Shweta A. Chitharanjan
- RD_CRC team (Drs - Deepali, Tejashree, Snehal, Smita, Asmita, Madhura, Kirtee)
|
Topic – Training to EC members –
1. New Drugs and Clinical Trial Rules, 2019
2. EC SOP version 18 |
4th July 2019 |
Dr Vaijayanti V. Pethe –
- Meeting agenda
- SOP - Version 18 updates
Dr Avinash L. Joshi, Chairman, EC, DMHRC -
Training on New Drugs and CT rules, 2019
All EC members participated in the exchange.
Dr Shweta A. Chitharanjan -
Preparation of training documents
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In-house research at DMHRC - "Caring for every project and learning from every project"
Organizers – Dr Gauri A Oka and Dr Vaijayanti V Pethe |
23rd June 2019 |
Patron, support and Director –
Dr Dhananjay S. Kelkar
Program moderator –
Dr. Gauri A. Oka
Speakers–
Dr. Vaijayanti V. Pethe (Preamble)
Dr. Swapna Naik (Awareness under GA study)
Dr. Suneel Godbole (CARS study)
Dr. Anup Tamhankar (GPER study)
Dr. Sumant Patil (ETT length study)
Dr. Archana Ranade (Gait study)
Dr. Manisha Deshmukh (DASS in chronic wounds)
Dr. Shilpa Kalane (Colostrum study)
Dr. Ashish Ranade (YouTube study)
Dr. Sonali Pingley (Ayurvedic Gargles study)
Dr. Pramod Patil (HRPF study)
Dr. Malathi Panchawagh (POST study)
Program Logistics and coordination–
Aditi Deshpande
Pooja Uchale
Dr. Sonu Hadke
Devika Joshi
|
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NABH surveillance (follow-up) site-visit for EC accreditation |
7 June 2019 and 8 June 2019 |
Patron, support and Director – Dr Dhananjay S. Kelkar (DMHRC)
Opening meeting (7th of June) presentations by –
–NABH assessors
–Dr Vaijayanti V. Pethe (DMHRC)
All members contributed to discussion and exchange.
Closing meeting (8th of June)
Presentation by NABH Principal assessor
Q&A session for EC members
Data compilation and preparation of documents
Dr Shweta A. Chitharanjan (DMHRC)
|
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Logistics and management policy for facilitation and implementation of In-house research by RD staff and DMHRC consultants. |
17 May 2019 |
Dr Dhananjay S. Kelkar |
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Basics of research methods for surgery residents and a review of randomized controlled trials in surgery |
07 May 2019 |
Dr Gauri A. Oka |
Biomedical research and innovation – Opportunities for collaboration between clinicians and technologists.
Organizers – Dr Gauri A Oka and Dr Vaijayanti V Pethe |
03 March 2019 |
Patron and support –
Dr Dhananjay S. Kelkar
Speakers–
Dr Gauri Oka
Dr Vaijayanti Pethe
Key speaker–
Dr. V. Premnath, BTech (IIT Bombay), PhD (MIT, USA)
Head, NCL Innovations and Director, Venture Centre, Pune
Panel discussion – entrepreneur bio-technologists and team members from Venture Centre
Logistics and coordination–
Mrs Aditi A. Kulkarni
Ms Aditi Deshpande
Mrs Sonal Jadhav
|
|
NABH surveillance visit preparation for EC accreditation - awareness and training - Part II |
01 March 2019 |
Dr Vaijayanti V. Pethe –
Meeting agenda
EC monitoring updates –
Dr Shweta A. Chitharanjan
Ms Jiteshri V. Raut
All members participated in the discussion
|
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NABH surveillance visit preparation for EC accreditation - awareness and training - Part I |
25 January 2019 |
Dr Vaijayanti V. Pethe –
Preamble presentation and round table discussion with EC members.
All members participated in the discussion
Preparation of training documents –
Dr Shweta A. Chitharanjan
Ms Jiteshri V. Raut
|
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Protocol writing for DNB students |
04 December 2018 |
Dr Gauri A. Oka (In-charge, In-house research, RD)
|
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Research overview and updates to Management and managers of DMHRC |
29 November 2018 |
Dr Vaijayanti V. Pethe – Structure and functioning of RD, DMHRC –
and at-a-glance overview of IHR, CTR and translational research endeavors by Consultants of DMHRC
Dr Gauri A. Oka – Landscape of In-house research at DMHRC
Data compilation –
Dr Shweta A Chitharanjan, CTR data
Mrs Aditi A Kulkarni, IHR data
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DMHRC- ERI meet - Ethics Symposim – Awareness program on ICH-GCP (Revision 2),Clinical research regulations and NABH process.
Organizers – Dr. Pethe V. (DMHRC, Pune) and Dr. Ghooi R. (ERI, Pune) |
25 November 2018 |
Patron and Support –
Dr. Dhananjay S. Kelkar (DMHRC)
Program moderator –
Dr Ravindra Ghooi (ERI)
Dr Dhananjay S. Kelkar – Opening meeting remarks (DMHRC)
Dr Chetan Deshmukh – ICG-GCP guidelines with clinical scenarios (DMHRC)
Dr Ravindra Ghooi – Awareness on Drug and Clinical trial rules_2018 (ERI, Pune)
Dr Arun Bhatt – NABH accreditation process
Dr Vaijayanti V. Pethe – Speaker introduction and vote of thanks (DMHRC)
Co-ordination, registration and logistics –
Dr Shweta Chitharanjan and Ms Jiteshree Raut (DMHRC)
|
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EC SOP - Revision of Version 15 – and Training on Version 16 (Effective 31st December 2018) |
13 November 2018 |
Dr Vaijayanti Pethe - round table discussion with EC members on SOP updates
All members participated in the discussion
Dr Shweta Chitaranjan -
Preparation of initial draft
Ms Jiteshri Raut -
Training evaluation preparation |
|
Training for Consultants, CRCs and research staff - "Regulations in Clinical Trial Research - Approach to culture of compliance"Organizers - Dr Shweta A. Chitharanjan and Dr Vaijayanti V. Pethe |
13 July 2018 |
Saurabh Naik, Strategic Site Relationship Manager, IQVIA Amit Choudhary, Clinical Operations Quality Manager, IQVIA |
|
Updates from ERI workshop, Ruby Hall, Pune (19 May 2018) Topics included ICH-GCP and regulatory updates. |
29 June 2018 |
Dr Vaijayanti V. Pethe - All EC members participated in the discussion. |
|
Vital considerations and approaches to meaningful research
[2 credit points awarded by MMC] – IHR research CME
Organizers - Dr Gauri A. Oka and Dr Vaijayanti V. Pethe
|
04 Feb 2018 |
Patron and Support – Dr Dhananjay S. Kelkar
Program moderator & Organizing Secretary –
Dr Gauri A. Oka
Dr. Vaijayanti V. Pethe
Dr. Gauri A. Oka
Dr. Anita Kar
Dr. Sundeep Salvi
Mrs Vasumathi Sriganesh
Dr. Asawari Kanade
Mrs Sheetal Deshpande
Dr. Anuradha Sovani
Dr. Ravindra Ghooi
Co-ordination, registration and logistics –
Mrs Aditi A. Kulkarni
Ms Jiteshri Raut
Ms Sonal Kamble
Ms Aditi Deshpande
|
ISCR-ERI meet: Capacity building of Ethics Committee members – training and updates on ICH-GCP (Revision 2), regulatory and NABH guidelines.
Organizers - Dr Ghooi R (ERI) and Dr Pethe V (DMH) |
28 Oct 2017 |
Program moderator –
Dr Ravindra Ghooi (ERI)
Dr Dhananjay S. Kelkar - Welcome address (DMH)
Dr Kedar Nayak - ISCR info (GlaxoSmithKline and ISCR)
Dr Shweta Pradhan - ICH-GCP- R2 updates (Quintiles)
Dr Sanish Davis - Regulatory updates and NABH accreditation process (Covance and ISCR)
Dr Vaijayanti V. Pethe - Vote of thanks (DMH)
Co-ordination, registration and logistics –
Dr Shweta Chitharanjan (DMH) and
Ms Jiteshree Raut (DMH)
|
|
EC SOP - Version 15 training (Effective 05 September 2017) |
31 Aug 2017 |
Dr Vaijayanti Pethe |
|
NABH assessor site-visit opening meeting: Structure and functioning of Research Department at DMH |
28 July 2017 |
Dr. Vaijayanti Pethe |
|
Awareness talk on Biotechnology Ignition Grant (BIG -11) under DBT-BIRAC (Govt of India) grant schemes |
25 July 2017 |
Dr. Shalini Singh, PhD (Senior Associate, Grants Program - operated by Venture Centre, NCL Innovation Park, Pune)
Organized by: Dr. Gauri Oka |
1. Sample size calculation, levels of evidence - and categories of recommendation (Lecture)
2. Choosing a topic for DNB thesis. |
4 July 2017 |
Presenter: Dr. Muralikrishna (2nd year DNB trainee)
Moderator: Dr. Gauri Oka, MBBS, MPH |
Updates from "Training Program on Implementation of NABH Accreditation of Ethics Committees", April 28-29,
Breach Candy Hospital, Mumbai – Part III – EC SOP revisions and updates_Version 13 (May 2017) |
25 May 2017 |
Dr Vaijayanti V. Pethe – presentation and round-table discussion with EC members.
All members participated in the discussion. |
Updates from "Training Program on Implementation of NABH Accreditation of Ethics Committees", April 28-29,
Breach Candy Hospital, Mumbai – Part II – Training on standards (10) and elements (49)
|
16-18 May 2017 |
Dr Vaijayanti V. Pethe – round-table exchange and discussion with Ethics Committee members.
All members participated in the discussion.
|
|
Updates from "Training Program on Implementation of NABH Accreditation of Ethics Committees", April 28-29,
Breach Candy Hospital, Mumbai – Part I – Introduction to accreditation process
|
10 May 2017 |
Dr Vaijayanti V. Pethe |
|
Assessment of impact of capacity building of gynecologists in Pune City regarding knowledge, attitude and practice of no-scalpel vasectomy (NSV): Hands-on workshop and training in NSV |
07 May
2017 |
Dr. Girish Godbole, MD
Dr. Gauri Oka, MBBS, MPH
and external faculty (Dr. RCM Kaza, Dr. Baljit Kaur, Dr. Chandan Bortamuly, Dr. Aruna Ojha) |
|
Audio Video Consent Guidelines - Essential elements for Informed consent process for clinical trial research |
10 Mar 2017 |
Dr Dhananjay S Kelkar |
|
GCP refresher training |
7 Oct 2016 |
Mr Saurabh Naik and Dr Sagar Vaze (Quintiles) |
|
Searching PubMed & Reference Management using Mendeley workshop |
28 Aug 2016 |
Ms. Vasumathi Sriganesh
(Masters in Library & Information Sciences) |
|
Statistical Methods |
18 Oct 2015 |
Dr. Asawari Kanade,
(Ph.D., Statistics) |
Protocol writing, study design –
and methodology |
15 Oct 2015 |
Dr. Gauri Oka,
(MBBS, MPH) |
|
Recent regulatory updates – and Site SOPs |
4 Sep 2015 |
Dr Sangita Singh and Dr Nomita Bhandari (Quintiles) |
|
Overview of Regulatory updates in clinical trials |
18 Jun 2015 |
Dr. Vaijayanti V. Pethe,
(Ph.D., Biochemistry) |
|
Critical appraisal of a research paper |
17 May 2015 |
Dr. Anita Kar,
(Ph.D., Cytogenetics) |
Updates from CDSA workshop, Pune (Feb 11-12, 2015) –"Current Regulatory Requirements for Members of
Institutional Ethics Committee –An Awareness Program" |
19 Mar 2015 |
Dr. Vaijayanti V. Pethe,
(Ph.D., Biochemistry) |
|
Basic Biostatistics for Clinicians Workshop |
1 Mar 2015 |
Dr. Kannan Sridharan, (MBBS, MD, DM) |
|
Why community doctors should do research? – Guest Lecture |
15 Feb 2015 |
Dr. Shantanu Patil,
(MS, Orthopaedics) |
|
Research Methodology Workshop |
4 Jan 2015 |
Dr. Anita Kar,
(Ph.D., Cytogenetics) |
|
Recent updates in regulatory guidelines with special focus on Audio Video Consent (AVC) |
16 Dec 2014 |
Mr. Saurabh Naik, (Quintiles) |
|
Research Methodology Workshop |
19 Oct 2014 |
Dr. Anita Kar,
(Ph.D., Cytogenetics) |
|
GCP training |
8 Nov 2013 |
Ms Snehal Chalke (Pfizer) |
|
ICH GCP training |
18 Jul 2013 |
Dr Anish Sule (Quintiles) |
|
"Ayu Soft" software |
29 Apr 2013 |
Dr Pramod Dhawale |
|
Revised SOP and GR updates |
21 Mar 2013 |
Dr. Avinash L. Joshi, Chairman, IEC, DMHRC |
|
ICH GCP training |
22 Feb 2013 |
Mr. Saurabh Naik (Quintiles) |
|
ICH GCP |
22 Feb 2013 |
Quintiles |