My CV MR. 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 to 13/01/11) Current CTC= 4.5 lac pa EDUCATIONAL DETAILS:Professional Qualification Master of Pharmacy (Pharmacology) Name of the College : Poona College of Pharmacy Name of the University : Bharati Vidyapeeth Deemed University Percentage of Marks : 67% (First class) : Year of passing July 2006 Bachelor in Pharmacy (B. Pharm) Name of the College : Dept. of Pharmaceutical Sciences Name of the University : HNB Garhwal University, Uttaranchal. Percentage of Marks : 66.27% (First class) : Year of Passing 2004 H. S. C. (12th ) Name of the College : Govt. Inter College Faizabad Board : Uttar Pradesh Allahabad Percentage of Marks : 61% (First class) : Year of Passing 1995 S. S. C. (10th ) Name of the College : Govt. Inter College Faizabad Board : Uttar Pradesh Allahabad Percentage of Marks : 66.67% (First class) : Year of Passing 1993 Other: GATE qualified with 86.56 percentile in 2004. ADDITIONAL Certificate of ICH GCP training from Vaatsalya Healthcare Solutions Pvt. Ltd. Bangalore.

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My CV EXPERIENCE DETAILS: PROFILE IN Quantum Limited:

Worked as a Technical Associate Officer (CRA) - Clinical Research in CROQuantum Limited (A Clinical Research Organization, Pune, Maharashtra) Since August 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 approval and 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 supply requirement. Responsible for preparation of Clinical Trial Report. PROFILE IN Torrent Research Centre: BA/BE STUDIES Protocol Designing & Review according to regulatory guidelines and in house SOP for various kinds of BA/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 Health Canada

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My CV

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, CRFs and 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 (especially Neuropsychiatry, Cardiology) Investigator Selection and site training (GCP and relevant regulatory requirements) 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 different regulatory markets. 2. Planning and management of Phase III clinical studies for DCGI submission. 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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My CV 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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My CV 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 Sex Marital Status Nationality Language Hobbies Permanent Address S/O Sri Ram Achal Maurya Vill - Muradabad Post Makhadoom Baramadpur Dist Faizabad (U.P.) 224159 Phone - 9839174755 (Home) Place: Ahmedabad Mobile: 9974407556 : : : : : : 8th March 1979 Male Married Indian English, Hindi Reading, Listening Music and Traveling Correspondence Address C/17,Bhagwat Nagar Society. Near Gulab Tower, Sola Road Thaltej, Ahmedabad, Gujarat

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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My CV 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 Dr. Johesh Mahajan IVP- Clinical Research Lambda Therapeutics, Ahmedabad 2. Dr. Ambrish Srivastava GM-Clinical Research Torrent Research Centre, Gandhinagar 3. Dr. Hardeep Wadhwa President- Ind Swift limited Om Prakash Maurya Date: 22/02/2012 1.

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