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My CVMR. OM PRAKASH MAURYA

omprakash_mph@rediffmail.com, M- 9878038710

Working as Asst. Manager- Clinical Research & Regulatory Affairs in

Ind-swift Limited, R & D Centre, Panchkula, Haryana since January 2011.

Total Experience in Clinical Research: 5 Years 5 monts

Experience in Quantum Limited: 1.0 Year (1/8/06 to 21/07/07)

Experience in Torrent Research Centre: 3 year & 6 months (23/07/07 to13/01/11)

Current CTC= 4.5 lac pa

EDUCATIONAL DETAILS:-

Professional QualificationMaster of Pharmacy (Pharmacology)Name of the College : Poona College of PharmacyName of the University : Bharati Vidyapeeth Deemed UniversityPercentage of Marks : 67% (First class)

: Year of passing July 2006

Bachelor in Pharmacy (B. Pharm)Name of the College : Dept. of Pharmaceutical SciencesName of the University : HNB Garhwal University, Uttaranchal.

Percentage of Marks : 66.27% (First class) : Year of Passing 2004H. S. C. (12th )Name of the College : Govt. Inter College FaizabadBoard : Uttar Pradesh AllahabadPercentage of Marks : 61% (First class) : Year of Passing 1995S. S. C. (10th )Name of the College : Govt. Inter College FaizabadBoard : Uttar Pradesh AllahabadPercentage of Marks : 66.67% (First class)

: Year of Passing 1993

Other: GATE qualified with 86.56 percentile in 2004.

ADDITIONAL

Certificate ofICH GCP training from Vaatsalya Healthcare Solutions Pvt. Ltd.Bangalore.

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EXPERIENCE DETAILS:

PROFILE IN Quantum Limited:Workedas a Technical Associate Officer (CRA) - Clinical Research in CRO-Quantum Limited (A Clinical Research Organization, Pune, Maharashtra) SinceAugust 2006 till July 2007.

Responsible for designing of clinical trial protocol, Case Report Form(CRF) and Informed Consent documents.

Site Screening/feasibility for various therapeutic segments (CNS, CVS,Arthritis Respiratory System and Colon Cancer) and monitoring of study.

Responsible for submitting the required documents for IRB/IEC approvaland DCGI approval.

Responsible for meeting with Principal Investigator and discus regarding

the study protocol. Responsible to discus with sponsor for the studies related matters.

Responsible for coordination of sites and management of trial supplyrequirement.

Responsible for preparation of Clinical Trial Report.

PROFILE IN Torrent Research Centre:BA/BE STUDIES

Protocol Designing& Review according to regulatory guidelines and in houseSOP for various kinds ofBA/BE studies. Key exp. as below.

App. 100 protocol designed for BA/BE studies for different regulatory

App. 60 CSR writing for regulatory submission

Pharmacokinetic/Pharmacodynamic end point study

Bioequivalence in psychiatric patients

Steady state study

Food effect study

Conventional BE study

Guidelines followed:

USFDA, ANVISA (Brazil), MHRA (UK), TGA, EMEA, DCGI and HealthCanada

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CRF Designing & Review

Report writing and submission to various regulatory authorities within

timelines

Investigator Brochure preparation

SOP preparation and system up gradation

Audit face and Regulatory Query resolution

IEC responsibility

Organize meeting and approval procedures of Protocols, CRFsand ICFs

SAE reporting and Periodic safety reporting

LATE PHASE (III & IV) CLINICAL TRIALS

Protocol development

Essential Documents preparation and co-coordinating ethics approval

Site Screening/feasibility for various therapeutic segments (especiallyNeuropsychiatry, Cardiology)

Investigator Selection and site training (GCP and relevant regulatoryrequirements)

Site development

Periodic Monitoring

Source data verification and Data cleaning

Data management Preparation of Clinical report and submission to authority

Site close-out and regulatory compliance

Medical writing

CURRENT JOB RESPONSIBILITIES

Key Profile in Ind-Swift Limited

1. Planning and management of Bioequivalence studies for differentregulatory markets.

2. Planning and management of Phase III clinical studies for DCGIsubmission.

3. Review of Protocol, Report for BA/BE/Clinical Trial studies.4. Handling of Regulatory Queries.5. Selection of CRO for Bioequivalence and Clinical Trial studies.6. Monitoring of BA/BE/Clinical Trial studies.7. Review and Finalization of Clinical Expert (Module 2 and Module 5).

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8. Checking of Dossier as per Different Regulatory requirements.9. Assistance to 3 to 4 team person for different aspects for Dossier.

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SYMPOSIUM / CONFERENCES ATTENDED

Rheology of Pharmaceutical and Cosmetic Product organized on

Monday 18th Aug 2003 by Haake Instrument India Pvt. Ltd. Pune.

Seminar on Voltage gated ion channels by David J.Triggle,

Professor, School of Pharmacy and Pharmaceutical Sciences,

University of Buffalo, NY, USA, in Poona College of Pharmacy, Pune.

National seminar on trends in drug discovery Poona College of

Pharmacy, Pune.

National workshop on Clinical Trials: scope, challenge, regulation and

methodology of working in India sponsored by ICMR and conducted at

S.J Thakkar Pharmacy College, Rajkot on 15th Sept., 2007.

National workshop on Clinical Research and Regulatory Affairs

sponsored by ICMR and conducted at K.B. Institute of Pharmaceutical

Education and Research, Gandhinagar on 26th April 2008.

PERSONAL

Date of Birth : 8th March 1979Sex : MaleMarital Status : Married

Nationality : IndianLanguage : English, HindiHobbies : Reading, Listening Music and Traveling

Permanent Address Correspondence AddressS/O Sri Ram Achal Maurya C/17,Bhagwat Nagar Society.Vill - Muradabad Near Gulab Tower,Post Makhadoom Baramadpur Sola RoadDist Faizabad (U.P.) 224159 Thaltej,Phone - 9839174755 (Home) Ahmedabad, Gujarat

Place: AhmedabadMobile: 9974407556

Publication:

S.L. Bodhankar, P.A. Thakurdesai, Om Prakash Maurya. Effect of

Ondansetron (RS) and its Enantiomers in QTc interval in rats; Online

publication in Journal of Pharmacology, 2006.

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HR Mehta, AS Srivastava, SK Shah, OP Maurya, S Manikumar and DS

Patel. Evaluation of Steady State Pharmacokinetics and Safety of

Duloxetine Major Depressive Patients After Multiple Dosing in Hospital Set

up. Pharma Science Monitor an International Journal of Pharmaceutical

sciences, Online Published (2010), www.pharmasm.com.

REFERENCES

1. Dr. Johesh MahajanIVP- Clinical ResearchLambda Therapeutics, Ahmedabad

2. Dr. Ambrish SrivastavaGM-Clinical ResearchTorrent Research Centre, Gandhinagar

3. Dr. Hardeep WadhwaPresident- Ind Swift limited

Om Prakash MauryaDate: 22/02/2012

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