Regulatory Affairs, Clinical Trial : Resume CV

[bhavik_garach]

Curriculum Vitae :
NAME : Garach Bhavikkumar Dineshkumar
E-Mail Id :bhavik.garach146 AT gmail.com

CAREER OBJECTIVE :
- To be an asset to a professionally managed organization by applying acquired knowledge and skills to achieve organizational goals.
- To make a challenging presence in Pharmaceutical organization, that encourages growth and career development by utilizing technical expertise, innovative, novel approaches, and interpersonal skills.

EDUCATIONAL QUALIFICATIONS :
Course Board/University School /Institute Year of passing Percentage / GPA :
M.Pharm. (Pharmacy Practice) National Institute of Pharmaceutical Education and Research (NIPER). NIPER, Hajipur. 2008-10 8.63 GPA
B.Pharm. Hemchandracharya North Gujarat University, Patan. Shri Sarvajanik Pharmacy College, Mehsana. 2004-08 63.62%
12th GHSEB Shri M.B.Karnavat High School, Palanpur. 2004 83.77%
10th GSEB Shri M.B.Karnavat High School, Palanpur. 2002 77.57%

ACHIVEMENTS :
- Qualified in GATE-2007, IIT Kanpur.
- Qualified in NIPER-JEE, 2008.

INDUSTRIAL TRAINING :
- B.Pharm. - 95 days industrial training at Ronak Laboratory as a part of curriculum.
- M.Pharm. - Second year project pursuing in Torrent Research Centre.

AREA OF INTEREST :
- Clinical Trial
- Regulatory Affairs
- Bioavailability and Bioequivalence Studies

M.PHARM. PROJECT DETAIL :
- Project Title :
“An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Single-Dose Comparative Bioavailability Study of FDC of Amlodipine 10mg and Valsartan 320mg tablet [Test formulation, Torrent Pharmaceuticals Ltd., India] versus Exforge® 10/320mg tablet containing Amlodipine 10mg & Valsartan 320mg [Reference formulation, Novartis, USA] in Healthy Human male Volunteers under Fed Conditions.”
- Place of Work : Torrent Research Centre, Village Bhat, Gandhinagar.
- Duration of Work : 8 months.
- Work During Project Work at TRC :
- Participation in Preparation of BE-NOC and T-Licence for various products.
- Participation in Preparation of Protocol for Clinical Trial and BE study.
- Participation in Preparation of Informed Consent Forms for Clinical trial and BE study.
- Participation in Preparation of Case Report Forms for Clinical trial and BE study.
- Participation in Preparation of Study Report for Clinical Trial and Bioequivalence study.
- Participation in Preparation of Expert Report for various products for Europe submission.
- Participation in Preparation of Package Inserts/Prescribing Information for various products.
- Participation in Preparation of PSUR for DCGI submission.
- Data Compilation and Data Entry Verification for Clinical Trial and BE Study.

TECHNICAL SKILLS :
Clinical :
- Knowledge about Schedule Y.
- Knowledge about ICH-GCP Guidelines.
- Guideline of Bioavailability and Bioequivalence for CDSCO, US-FDA, EMEA & Canada.

Computer proficiency :
- Microsoft Office
- Internet Surfing

CONFERENCES/WORKSHOPS ATTENDED :
- Participant in International Symposium on “Recent Pharmaceutical Research Trends for Orphan Diseases” Organized By NIPER-Hajipur & Delhi University, In Patna (Jan-2010).
- Participant in India Pharma Summit, 2009 at Mumbai, organized by Dept of Pharmaceutical, Ministry of Chemical & Fertilizers, Govt. of India. (Dec-2009).
- Attended CPhi exhibition held in Mumbai (Dec-2009).
- Participant in MSF Scientific writing workshop held at RMRIMS, Patna (Oct-2009).
- Attended 60th Indian Pharmaceutical Congress held at Delhi. (Dec-2008).

OTHER CURRICULUM ACTIVITY :
- Under went 300 hrs of training at 3 different clinical wards of Medicine, General Surgery, Paediatrics at NMCH & RMRIMS, Patna.

PERSONAL DETAILS :
- Date of Birth : 14th June 1987.
- Gender : Male.
- Marital Status : Unmarried.
- Nationality : Indian.
- Language Proficiency : English,Gujarati,Hindi.

All above mention information is true and correct to the best of my knowledge.

Yours sincerely,
Bhavik Garach

[Guest]

CURRICULUM VITAE :
Sheetal Prakash Sawant
Email : sheetal.rocks90 AT gmail.com

OBJECTIVE :
To obtain an entry level position in the clinical research and Regulatory departments to develop essential skills and gain experience in the areas of Regulatory Affairs and Quality Assurance of drugs and biological products.

EDUCATION :
Course College/University Year Passed :
Advanced Post Graduation Diploma in Drug Regulatory Affairs Global institute of regulatory affairs (GIRA) Institute, Pune 2011
Basic Diploma Clinical research Management & Regulatory Affairs Haffkine Institute for Training Research & Testing, parel, Mumbai. 2010
Bsc.Biotechnology Mumbai University 2009

Regulatory Skills :
Knowledge of IND, NDA, ANDA application submission.
Knowledge of USDMF, EUDMF preparation and CTD format (specially QUALITY MODULE)
Knowledge of Global Regulatory Submissions.
Knowledge of FDA, TGA, MCC and ICH Guidelines.
Knowledge of drug and cosmetic act, schedule Y, TGA, EMEA, USMHRA
Knowledge of Clinical Research Phases.
Online quintiles certified cource done on introduction to the clinical development process and ICH good clinical practice for clinical trial sites.

Conferences and Workshops attended :
- Attended and Participated 13th IDMA conference, 2010 held at Mumbai, Maharashtra.
- Attended workshop on DRUG REGULATORY AFFAIRS-QC/QA on 27thSEPT. 2009, organized by Asian institute of health sciences, Mumbai.
- Attended workshop on ICH GCP AND PHARMACOVIGILANCE on 4thOCT. 2009, organized by Asian institute of health sciences, Mumbai.
- Attended workshop CDM & MEDICAL WRITING on 11th Oct 2009, Organized by Asian Institute of Health Science, Mumbai

PROJECTS INVOLVED :
1. Organization : Milan Laboratories India Pvt Ltd, Kamothe, Panvel, Mumbai.
Period : One and Half Months.
Subject : To Understand Regulatory Affairs Profession and work on it.
Synopsis :
Review the documents used in QA/QC/Regulatory Affairs Viz. BMR, BPR, STP, ATP, SOP, Product Recall Protocol and Stability Protocol.
Regulatory Affairs Documents : Review of DMF and Assisted in Preparation of CTD format Dossier.
Project guide : Mrs.Sharvari Deshpande, Quality Operation Head

2. Project on Committee for Proprietary Medicinal Product (CPMP) dossiers for marketing authorization of nisoldipine tablet

3. Prepared a mock dossier on dypiridamole 25 mg tablet as per US guidelines.

STRENGTH :
Positive thinker.
Quick adaptiveness.
Time consciousness.
Team worker.
Ability to multi- task with strong organization skills.

COMPUTER PROFICIENCY :
MSCIT in Computers from Govt. Of India
Computer Fundamentals.
Internet.tools
MS Office.

[Guest]

i am hiral shah and i have completed my bpharma from Bangalore and than i did pgdm in clinical research from xcellon institute ahmedabad now i am searching job related trial or clinical research coordinator. my email i.d. is shahhiral2010 AT yahoo.com