CURRICULUM VITAE

(CV TITLE – *.* YEARS EXPERIENCE IN SALES & MARKETING AND 5 YEARS EXPERIENCE IN CLINICAL RESEARCH OF CARDIAC DRUGS AND MEDICAL DEVICES – LIKE CORONARY STENTS)

NAME Mr. Ashok Thakkar Male / 34 Yrs

QUALIFICATIONS

1. Ph.D. (Clinical Pharmacology) Thesis Submitted L.M. College of Pharmacy, Gujarat University, Ahmedabad, Gujarat, India.

2. M. Pharm (Clinical Pharmacy) June 2005 – July 2007 ARCP, Vallabh Vidyanagar, S.P. University, Gujarat, India.

3. M.B.A (Marketing) Aug. 2000-May 2002 S.K. School of Business Management, Patan, Hem. North Gujarat University, Gujarat, India.

4. B. Pharm Aug. 1997- July 2000 Maharastra College of Pharmacy, SRTM University, Maharastra, India.

PRESENT AFFILIATION:

PRESENT POSITION Medical Devices Consultant

OFFICE ADDRESS Central Drugs Standard Control Organization (CDSCO),

Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhawan, Kotla Road, Near Mata Sundari College,

ITO, New Delhi-110002

START DATE June 2011

PAST EXPERIENCE:

• I had worked as a Senior Clinical Trial Manager and Assistant Manager – Clinical Trials at Sahajanand Medical Technologies Private Limited, Surat for 3.5 years (Nov-2007 to May-2011).

• I had worked as a CRA and Clinical Trial Site Manager – Clinical Studies at Vibgyor Scientific Research Pvt. Ltd. at Ahmedabad for 1.4 year (Aug-2006 to Nov-2007) including project work.

• I had worked as a Medical Representative in GLAXOSMITHKLINE PHARMA. LTD. at Ahmedabad for 1.9 years (Jan – 2004 to Oct – 2005).

• I had worked as a Medical Representative at Macleods Pharma. Ltd. at Mehsana for 6 months (July – 2003 to Nov – 2003).

LICENSURE & MEMBERSHIPS:

Pharmacy Council of India: Registration no. G-14537

Lifetime membership-Indian Pharmacological Society, India (Registration no. LT-114)

JOB DUTIES at CDSCO, New Delhi:

● To collect, compile and analyse the scientific national, international data/regulation of

medical devices.

● To make relevant SOP’s, guidelines and notification for amendments in Schedule M-III

and M-IV to Drugs & Cosmetics Rules.

● Any other duties assigned by Drugs Controller General of India (DCGI) from time to

time

JOB DUTIES at Sahajanand Medical Technologies Pvt. Ltd.:

• Coordinating a clinical trial within the contractual timelines, deliverables and financial obligations

• Planning and execution of a project

• Managing a trial from site selection, startup and enrollment to close-out

• Managing clinical research associates' productivity, Contacting investigators and internal project teams

• Developing and implementing risk management strategies and contingency plans for clinical deliverables

• Ability to complete Quality Compliance Support (Audit, product quality and adverse report handling).

• Mentoring and training of the Clinical Research Associate

• Facilitating effective communication between investigative sites, the client and sponsor

• Responding to sponsor, client and federal regulatory requirements/audits

• Product training and management

• Medical writing and Regulatory submission

• Coordinate and update the international registrations of medical devices

• Prepare the administrative part of the dossier and the packaging texts

• Plan the registrations and renewals

INTERNATIONAL AND NATIONAL CLINICAL TRIALS MANAGED:

• Project Manager for Supralimus-Core™ pharmacokinetic Study.

Sponsor: Sahajanand Medical Technologies Pvt. Ltd.

• Project Coordinator for E-SERIES Registry and Infinnium-Core™ Registry.

Sponsor: Sahajanand Medical Technologies Pvt. Ltd.

• Team Member for a B1461001: Prospective Randomized Phase IV Open Label Comparative Study of Tranexamic Acid Plus Standard of Care Vs Standard of Care for the Reduction of Blood Loss in Patients undergoing Major abdominal Surgery,

Sponsor: Pfizer

• Team Member for Clopidogrel in MI study: An international, randomized, double blind, double dummy trial (OASIS 7).

Sponsor: Sanofi-Aventis Pharma

• Study Team member for a trial of Abciximab study:

Sponsor: Lupin Pharma. Ltd.

• Study team member of Polycap Trial

Sponsor: Cadila Pharma. Ltd.

• Study team member of Bivaflo Registry

Sponsor: Sun Pharma. Ltd.

• Team member for Phase III Study in MI (Plato Study).

Sponsor: Astra-Zeneca

• Team member of a Protect study.

Sponsor: Medtronic

• Team member of a e-Cypher study

Sponsor: Cordis

• Team member of Export study

Sponsor: Medtronic

INTERNATIONAL & NATIONAL CONFERENCES/MEETINGS ATTENDED:

Participated as a Faculty at the workshop on “Application of SPSS in Pharmaceutical Sciences” held on 24th April 2011 at L. M. College of Pharmacy, Ahmedabad.

Attended a workshop on Medical Devices Regulations sponsored by CDSCO and WHO at B. V. Patel PERD Centre, Ahmedabad held on 18-19 March, 2011.

Attended a conference on “Biomaterials, Tissue Engineering and Drug Delivery Systems” during February 10-12, 2011 by INDO-AUSTRALIAN Conference at Vallabh Vidyanagar, Gujarat.

Attended a training workshop on “Clinical Trials and Statistical Computing” during 15-19 March, 2010 by National Institute of Medical Statistics (Indian Council of Medical Research) at New Delhi.

Attended UGC sponsored National Workshop on “Medicinal and Pharmaceutical Statistics” organized by the dept. of statistics, Sardar Patel University, Vallabh Vidyanagar during 25-28 February, 2010.

Attended IPSCON, 2009 on December 10 – December 12, 2009 at Kolkata, India.

Attended IPS, 2008 on December 18 – December 20, 2008 at New Delhi, India.

Attended 59th annual conference Cardiological Society of India, 2007 on 6-9 December, 2007 at Hyderabad, India.

Attended Clinical Excellence Program on GCP conducted on 06th Oct 2007 by Sanofi Aventis.

Attended Investigator’s Meeting: OASIS 7 Study on Mar 31 – April 1, 2007 at Banglore, India.

Attended Investigator’s Meeting: PROTECT Study on 22, April 2007, Ahmedabad, India.

Attended the “workshop on Good Laboratory Practices (GLP) For Academia, Sponsored by Department of Sciences and Technology, Government of India” 24th and 25th November 2006, at the All India Institute of Medical Sciences, New Delhi, India.

Participated in International Diabetic Conference, Sponsored by Zydus-Cadila Pharma Ltd., Ahmedabad held on 1-4 February, 2007.

Publications/Presentations:

• Thakkar A, Parmar S, Mehta A. Biodegradable-polymer-based, sirolimus-eluting stent: Long-term clinical follow-up relusts from the prospective study. 4th World Congress, International Academy of Cardiovascular Sciences, 5th February, 2011.

• Thakkar A, Parmar S, Mehta A. Clinical safety & efficacy study of Bivalirudin & its comparison with Heparin in patients undergoing percutaneous coronary intervention. EuroIntervention. 2010; 6:67.

• Dr. Atul Abhyankar, Ashok Thakkar Interpretation of Clinical Trials. A special publication by association of physicians of Surat on the occasion of 31st Annual conference of association of physicians of Gujarat 23-24 January, 2010. Glimpses of Medicine 2010; VI, 18-37.

• Parmar SA, Thakkar AT, Jariwala A, Raval A, Tailor J, Mehta AA. Development and evaluation of novel biocompatible and biodegradable sirolimus eluting stent having biphasic release profile. Indian journal of Pharmacology 2009; 41(1), S157.

• Thakkar A, Parmar S, Mehta A. Comparative study of different stents on clinical outcomes following coronary stenting. Indian Journal of Pharmacology 2009; 41(1), S36.

• Thakkar A, Mahajan S, Mehta A. The risk of stent thrombosis and antiplatelet therapy. Journal of pharmacovigilance and drug safety 2008; 5 (1), 65-72

• Thakkar A, Mehta A, Patel B, Raykundaliya D. The short-term and long-term clinical outcomes following coronary stenting. Indian journal of Pharmacology 2008; 40 (2), S200

• Poster presentation: Thakkar A, Parmar S and Mehta A. "The short-term and long-term Clinical Outcomes Following Coronary Stenting" March 4 – 6, 2009, CRT 2009, Washington, USA

PERSONAL PROFILE:

Full Name : Ashok Suryakant Thakkar

Date of Birth : 13th November 1977

Marital Status : Married

Present Address : D-333A/1, Street No 12-11, B/h Street No 12,

Laxminagar, Delhi-110092

Mobile No : +91-844*******

Email ID : qw5kci@r.postjobfree.com

Languages known : English, Hindi and Gujarati

ACADEMIC BACKGROUND:

Degree Institute Year Percentage

M.Pharm ARCP, Vallabh Vidyanagar August-2007 68%

(Clinical Pharmacy) S.P. University, Gujarat, India.

M.B.A. S.K.S.B.M., North Gujarat May-2002 58%

University, Patan, Gujarat.

B. Pharm Maharastra College of Pharmacy, August-2000 70%

S.R.T.M. University, Maharastra.

D.Pharmacy L.M. College of Pharmacy August-1997 62% Ahmedabad, Gujarat, India.

HSC Gujarat Education Board March-1995 66%

SSC Gujarat Education Board March-1993 68%

References:

1. Prof. Anita Mehta

Professor & Head,

Department of Pharmacology, L. M. College of Pharmacy, Ahmedabad-38009, India

Phone: +91-942*******, Email: qw5kci@r.postjobfree.com

SIGNED: Ashok Thakkar November 9, 2011

Contact this candidate