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Clinical Pharmacology
Program Details
ICMR Clinical Pharmacology Workshop 2008
4 th -16 th February 2008
Dept. of Clinical Pharmacology
M S Building, 1 st floor, Seth G S Medical college & KEM Hospital ,
Parel, Mumbai- 400 012
Version date: 23 rd January 08
Day 1: Monday 4 th February 2008 |
Venue: Medicine Seminar Hall |
| TIME | Programme | Speaker | Organisation | Contact Details |
| 8.30-9.30 | Registration | |||
| 9.30-9.35 | Welcome | Dr Nithya Gogtay | KEM Hospital Mumbai 4000 12 | 9820495836 njgogtay@hotmail.com |
| 9.35-9.40 | Introduction to workshop | Dr Nithya Gogtay | KEM Hospital Mumbai 4000 12 | 91 22 24136051 Ext 2715 dcpkem@vsnl.com |
| 9.40-10.30 | Key note address | Dr. K. Rammoorthy (NF) | ||
| 10.30-11.00 | Address by Guests of Honor | Dr. Ashok Vaidya (NF) Dr.Daniel Joseph (NF) Dr KG Nair (NF) | avaidya@vsnl.com | |
| 11.00-11.15 | Tea Break |
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| 11.15-11.30 | Photo Session |
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| 11.45-12.45 | Presentation by participants of their departments activities, institute’s background, future plans | Participants | ||
| 12.45 -2.00 | Lunch |
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| 2.00-2.30 | Presentation by participants of their department’s activities, Institute’s background and future plans | Participants | ||
| 2.30-3.30 | Formulating a research question | Dr Dilip Karnad (A) | KEM Hospital Mumbai 4000 12 | 9892114002 drkarnad@rediffmail.com |
| 3.30-4.00 | Tea Break |
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| 4.00-5.00 | New drug development | Dr Viraj Rajadhyaksha (A) | Pfizer ltd Mumbai 400 102 | 9820540678 viraj.rajadhyaksha@pfizer.com |
| 5.00-5.30 | Exercise 1: Formulating a research question (4 groups) | All participants | ||
Day 1 Co-ordinators: All DCP staff.
Day 2: Tuesday 5 th February 2008 |
Venue: Seminar Room DCP 1 st Floor MS Building |
ETHICS
TIME |
Programme
|
Speaker |
Organisation |
Contact details |
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1- Ethics Module |
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9.00-10.00 |
Ethics Committee and their responsibilities |
Dr Kaizad Damania (A) |
Wadia Hospital Mumbai 4000 12 |
9869117615 kaizad@vsnl.com |
10.00-10.30 |
Tea Break |
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10.30-11.10 |
Ethics in animal research |
Dr Sandhya Kamat (A) |
KEM Hospital Mumbai 4000 12 |
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11.20-12.00
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Ethics in clinical research |
Dr. A N Supe (A) |
KEM Hospital Mumbai 4000 12 |
9869337600 avisupe@vsnl.com |
12.10-12.30 |
Informed Consent + Patient Information Sheet |
Dr Padmaja Marathe (A) |
KEM Hospital Mumbai 4000 12 |
Ext. 2515 |
12.30-1.30 |
Lunch |
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1.30- 2.15 |
Ethics in Pediatrics |
Dr S B Bavdekar (A) |
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2.15 -3.00 |
Tea Break |
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3.00-3.30 |
Ethical issues in Psychiatry |
Dr S R Parkar (A) |
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3.30-4.30 |
Presentation by participants of group exercise 1(formulating a research question) |
All Participants |
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Chairperson : |
4.30-5.30 |
Exercise 2:- Group exercise on protocol designing |
All Participants |
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Day 2 Co-ordinators: Vishal, Pooja
Day 3: Wednesday 6 th February 2008 |
Venue: Seminar Room DCP 1 st Floor MS Building |
STATISTICS
TIME |
Programme
|
Speaker |
Organisation |
Contact details |
9.00-9.45 |
Rational use of drugs |
Dr Yashashri Shetty (A) |
KEM Hospital Mumbai 4000 12 |
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9.45-10.45 |
Drug Utilization Studies |
Dr N N Rege (A) |
KEM Hospital Mumbai 4000 12 |
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10.45-11.00 |
Tea Break |
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2- Statistics Module |
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11.00-12.00
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Statistics in medical research-why and how (including illustrations) |
Dr N J Gogtay (A) |
KEM Hospital Mumbai 4000 12 |
9820495836 |
12.00-1.00 |
Sample Size Calculation |
Dr N J Gogtay (A) |
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1.00-2.00 |
Lunch |
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2.00-3.00 |
Exercise 3: 2 problems on statistics |
All participants |
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Dr N J Gogtay |
3.00-3.30 |
Tea Break |
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3.30-5.30 |
Pharmacoepidemiology |
Dr N J Gogtay (A) |
KEM Hospital Mumbai 4000 12 |
9820495836 njgogtay@hotmail.com |
Day 3 : Co-ordinators: Dr Priti, Arpita
** How I did statistical analysis for my research Dr. Elesh Jain
Day 4: Thursday 7 th February 2008 |
Venue: Seminar Room DCP 1 st Floor MS Building |
Medical Writing
TIME |
Programme |
Speaker |
Organisation |
Contact details |
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Medical Writing Module |
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9.00-10.00 |
Writing a research paper |
Dr N J Gogtay (A) |
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10.00 -10.45 |
Critical evaluation of published paper |
Dr Sudeep Shah (A) |
Hinduja Hospital |
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10.45-11.00 |
Tea Break |
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11.00-11.45 |
Case Reports |
Dr S B Bavdekar (A) |
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11.45-12.45 |
Effective communication:- Scientific paper writing |
Dr. Philip Abraham (NF) |
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12.45-1.45 |
Lunch |
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1.45-2.45 |
Medical writing as career option |
Dr. Suhasini Sharma (NF) |
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2.45-3.00 |
Tea Break |
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3.00- 4.00 |
Pubmed search |
Ms. Vasumathi Sriganesh (NF) |
QMed Knowledge Foundation , Mumbai 400099 |
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4.00-5.00 |
Exercise :- Presentation of Protocol |
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Dr. Keya Lahiri (NF) |
Day 4: Co-ordinators: Meenal, Nitin
Day 5: Friday 8th February 2008 |
Venue: Pfizer Ltd. |
INDUSTRY VISIT
TIME |
Programme |
Speaker |
Organisation |
Contact details |
9.00-9.45 |
Departure from YMCA to Pfizer |
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Regulatory Module |
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10.00-10.30 |
ICH –GCP Guidelines |
Dr C N Potkar (A) |
Pfizer Ltd Mumbai 400 102 |
9323806172 |
10.30-11.00 |
Tea Break |
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11.00-12.00 |
Revised Schedule Y |
Dr C N Potkar (A) |
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Protocol Design Module |
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12.00-1.00 |
Protocol design for Phase I & II |
Dr Viraj Suvarna |
Pfizer Ltd Mumbai 400 102 |
9820006317 |
1.00-1.30 |
Lunch |
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1.30-2.30 |
Phase III & Post marketing surveillance (Phase IV studies) |
Dr Salil Shinde (A) |
Pfizer Ltd |
9324618087 |
2.30-3.15 |
Pharmacoeconomics & Pharmacogenomics |
Dr Sanish Davis (A) |
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Day 5: Co-ordinators: Shraddha, Shital
| Day 6: Saturday 9 th February 2008 | Venue: Seminar Room DCP 1 st Floor |
Miscellaneous
TIME |
Programme |
Speaker |
Organisation |
Contact details |
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Miscellaneous |
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9.00-10.00 |
10 ways to get your paper rejected |
Dr. B K Nayak (NF) |
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10.00-10.45 |
Avoiding Bias |
Dr. Usha Sharma (NF) |
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10.45-11.00 |
Tea Break |
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11.00-12.00 |
TDM OPD |
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12.00-1.00 |
Lunch |
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1.00-2.00 |
Stem Cell Research |
Dr Lakshmi Rajgopal (NF) |
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2.00 onwards |
Shopping at Linking Road |
Pooja, Swapnali, Shraddha, Nitin |
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**** |
Demo: HPLC for anti epileptic, Electrolyte Analyzer |
P Kadam, Balkrishna |
KEM Hospital Mumbai 4000 12 |
91 224136051 ext:2715 dcpkem@vsnl.com |
Day 6 Co-ordinators: Dr.Priti, Swapnali
| Day 7 Sunday 10 th February 2008 | Visit to Fashion Street And Mumbai Darshan. |
Co-ordinators: Dr.Priti, Nitin, Pooja, Shraddha
| Day 8: Monday 11 th February 2008 | Venue: Seminar Room DCP 1 st Floor MS Building |
TDM & ADR
TIME |
Programme |
Speaker |
Organisation |
Contact details |
|
ADR Module |
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9.00-10.00 |
Methods of assessment of ADRs in Dermatology |
Dr Uday Khopkar (A) |
KEM Hospital Mumbai 4000 12 |
9820055305 ukhopkar@vsnl.com |
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TDM Module |
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10.00-11.00 |
A]Setting up of TDM: |
Dr S S Dalvi |
KEM Hospital |
9820191772 |
11.00-11.30 |
Tea Break |
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11.30-12.30 |
Designing a CRF and discussion on a sample CRF with examples |
Dr. Chetan Desai (NF) |
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12.30- 1.30 |
Lunch |
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Therapeutic Areas Module |
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1.30- 2.30
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Clinical trials with anti asthma drugs and PFT demo |
Dr AU Athavale (A) |
KEM Hospital Mumbai 4000 12 |
9820104950 kempulmo@vsnl.com |
2.30-3.00 |
Tea Break |
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3.00- 3.30 |
Travel to Cipla (A) |
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3.30-4.30 |
PK PD of inhaled drugs and visit to Cipla limited |
Dr JA Gogtay (A) |
Cipla Ltd |
91-22 309 5521 - Ext. 412 jgogtay@cipla.com |
Day 8 Co-ordinators : Balkrishna , Swapnali
| Day 9: Tuesday 12 th February 2008 | Venue: Seminar Room DCP 1 st Floor MS Building |
Visit to Academic Institutions
TIME |
Programme |
Speaker |
Organisation |
Contact details |
8.30 – 9.00 |
Departure from YMCA to KEM Hospital |
|
|
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9.30 –12.00 |
Visit to NIRR |
Priya Menon Co-ordinator (A) |
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1.00-2.30 |
Lunch |
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2.30-4.30 |
Visit to TDM Lab, Sion |
(A) |
TDM lab, Sion |
022 - 24078300 |
Day 9 Co-ordinators: Prashant, Nitin
| Day 10: Wednesday 13 th February 2008 | Venue: Seminar Room DCP 1 st Floor MS Building |
Miscellaneous
TIME |
Programme |
Speaker |
Organisation |
Contact details |
|
Miscellaneous Module |
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9.00-10.00 |
Clinical trials with HIV drugs |
Dr Amar Pazare (A) |
KEM Hospital Mumbai 4000 12 |
9820572212 amarpazare@gsmc.edu |
10.00 –11.00 |
Good Clinical Practices |
Dr Vatsal Shah (NF) |
|
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11.00-11.30 |
Tea Break |
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11.30-12.15 |
Clinical Pharmacology and Nuclear medicine |
Dr Vikram Lele (A) |
Jaslok Hospital |
91-22-24933333 lele1@vsnl.com |
12.15-1.00 |
Regulatory requirements for the introduction of new drugs in India |
Dr Aamir Shaikh (A) |
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1.00-1.30 |
Lunch |
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1.30-2.15 |
Evaluation of drugs used in the intensive care unit |
Dr D R Karnad (A) |
KEM Hospital Mumbai 4000 12 |
9324324351 drkarnad@rediffmail.com |
2.15-3.00 |
QTc interval in drug development |
Dr D R Karnad (A) |
KEM Hospital Mumbai 4000 12 |
9324324351 |
3.00-3.30 |
Tea Break |
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3.30-4.30 |
Exercise 6 :- Group exercise on Bioavailability |
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Day 10 Co-ordinators: Shital, Shraddha
| Day 11: Thursday 14 th February 2008 | Venue: Seminar Room DCP 1 st Floor MS Building |
Pharmaco-Kinetics and Bioavailability
TIME |
Programme |
Speaker |
Organisation |
Contact details |
|
Pharmacokinetic Module |
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9.00–10.30 |
Principles of Pharmacokinetics |
Dr K Iyer (A) |
Bombay College of Pharmacy |
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10.30-10.45 |
Tea Break |
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10.45-11.45 |
Exercise 7: Pharmacokinetics : Problem Solving for PK |
Dr K Iyer (A) |
Bombay College of Pharmacy |
|
11.45-12.30 |
Dvelopment of bilogicals |
Dr Veena Jaguste (NF) |
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12.30-1.30 |
Lunch |
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1.30-2.30 |
Pharmacovigilance |
Dr NAK (A) |
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2.30-3.15 |
Role of a clinical pharmacologist in pharmaceutical industry |
Dr J A Gogtay (A) |
Cipla Ltd |
91-22 309 5521 - Ext. 412 jgogtay@cipla.com |
3.15-3.30 |
Tea Break |
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3.30-4.30 |
Bioavailability studies and their regulatory requirements in India with problem solving |
Dr Nomita Bhandari (A) |
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4.30-5.30 |
Clinical evaluation of drugs used in osteoporosis |
Dr. Prema Varthakavi (A) |
Nair Hospital , |
9224480560 premavar@hotmail.com |
5.30-6.00 |
Presentation by participants onExercise 8: Protocol for bioavailability studies |
All participants |
|
Chairperson : |
Day 11 Co-ordinators: Dr Priti, Pooja
| Day 12: Friday 15 th February 2008 | Venue: Seminar Room DCP 1 st Floor MS Building |
Therapeutic Areas
TIME |
Programme |
Speaker |
Organisation |
Contact details |
9.00-9.45 |
Report Writing |
Dr Arun Bhatt (A) |
ClinInvent ltd |
|
9.45-10.30 |
Good Teaching Practices |
Prof CV Patankar (NF) |
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10.30-11.00 |
Tea Break |
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11.00–11.45 |
TDM Applications in epilepsy with case discussion |
Dr S H Ravat (A) |
KEM Hospital Mumbai 4000 12 |
9820310850 |
12.00-1.00 |
Methods of assessment in infectious diseases |
Dr Sanjay Mehta (A) |
KEM Hospital Mumbai 4000 12 |
9820572212 |
1.00-1.30 |
Lunch |
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1.30-2.15 |
Clinical trials with anti ulcer agents |
Dr S J Bhatia (A) |
KEM Hospital |
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2.15- 3.00 |
Visit to Endocrinology dept for DEXA demo |
Dr Vyankatesh (NF) |
KEM Hospital Mumbai 4000 12 |
9122 24136051 ext: 2602 |
3.00-3.30 |
Tea Break |
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3.30-4.30 |
Reverse Pharmacology Approach for Traditional Medicines |
Dr Ashok Vaidya (NF) |
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4.30-5.30 |
Essentials for effective therapeutic drug monitoring |
Dr S S Dalvi (A) |
KEM Hospital Mumbai 4000 12 |
9820191772 sudeshsunil@rediffmail.com |
Day 12 Co-ordinators: Shital, Arpita
| Day 13: Saturday 16 th February 2008 | Venue: Seminar Room DCP 1 st Floor MS Building |
Miscellaneous
TIME |
Programme |
Speaker |
Organisation |
Contact details |
9.00-9.50 |
Clinical trials in Nephrology |
Dr N K Hase (A) |
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9.50-10.30 |
Clinical trials in Oncology |
Dr Purvish Parikh (A) |
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10.30-11.00 |
Tea Break |
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11.00-11.45 |
Pharmacoeconomic considerations |
Dr SM Sapatnekar (NF) |
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11.45-12.30 |
Preclinical toxicity studies from regulatory perspective (Inhalation drugs, vaccines and Biotech products) |
Dr P Naik (NF) |
Intox Pvt Ltd |
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12.30-1.00 |
Workshop Assessment, Valedictory function and Post Workshop Questionnaire |
All participants |
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1.00-2.00 |
Lunch |
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Day 13 Co-ordinators: Shraddha, Swapnali
A – Accepted, D – Declined, NF – not finalized