Resume
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Praveen Agarwal has over 3 years of experience in regulatory affairs and quality management. He cleared the WIPO exam in 2014 and is a lifetime member of APTI. His responsibilities include dossier compilation and regulatory submissions for pharmaceutical, plasma derivative, and biosimilar products to markets in ASEAN, Central and South America, Africa, South Asia, and India. He has a Master's degree in pharmacy with a focus on nasal product approval in Australia. His areas of expertise include global regulatory guidelines and requirements for multiple regions and countries.
Resume
- 1. 1 RESUME Praveen Agarwal ACHIEVEMENTS Cleared World Intellectual Property Organization (WIPO) exam-2014 Life Time Member of Association of Pharmaceutical Teachers of India (APTI's) TRAINING & CERTIFICATIONS Training at BIOPLUS LIFE SCIENCE in Drug Regulatory Department. General Course on Intellectual Property Right organized by World Intellectual Property Organization (WIPO), Geneva. PROFESSIONAL EXPERIENCE A work in Regulatory submissions and maintenance of Quality management System as Management Representative. 1. Plasmagen Biosciences Pvt. Ltd. & Trigenesis Lifesciences Pvt. Ltd. Bangalore 1.1 Experience: APRIL 2015- Till date 1.2 Designation: Executive Regulatory Affairs. 1.3 Roles & Responsibilities: Pharmaceuticals, Human Plasma Derivatives & rDNA products (Biosimilars) Dossier Compilation and submission for the following markets 1 ASEAN Market: Singapore, Malaysia, Indonesia and Vietnam 2 Central America & LATAM Markets: Argentina, Venezuela, Costa Rica, Panama, Nicargua, Columbia, Jamaica & Bolivia. 3 South Asian Market: India, Srilanka, Nepal and Bhutan. 4 African market: Tanzania, Mali & Nigeria. INDUSTRIAL TRAINING 1. Training at BIOPLUS LIFE SCIENCE in Drug Regulatory Department. 1.1 Experience: October 2014 to March 2015 1.2 Designation: Trainer in Quality Assurance And Drug Regulatory Affairs. 1.3 Roles & Responsibilities: a. Read the ICH guidelines, Reviewed and Arranged Dossier for Srilanka, U.K, Iran and UAE, Sample packing, Prepared Certificate of Analysis (COA), Master formula record (MFR) for pharmaceuticals and Nutraceuticals. b. Prepared Specification and Stability Study data for pharmaceuticals and Nutraceuticals. c. Revived Drug master file for pharmaceuticals and Nutraceuticals. CONTACT DETAILS Tel : +91-9538326249 e-mail: praveenagarwal61@gmail.com CAREER OBJECTIVE To build my career with the organization in the regulated field of pharmacy. I would like to serve the firm which can give me opportunity and challenge, to effectively utilize my skill, knowledge and work with the organization in the best possible way.
- 2. 2 2. Bescoat Pharmaceuticals Ltd. Part of Academic curriculum in Bachelors Degree. 2.1 Period: 6th July 2012 August 2012 2.2 Designation: Trainee 2.3 Roles & Responsibilities Various Documentation activities in Quality Control, Quality Assurance and Finished Good Section. PROJECTS Masters in Pharmacy under Regulatory Affairs Department Major: Regulatory Requirements for Approval of Nasal Products in Australia at Microlabs Ltd, Bengaluru. COMPUTER KNOWLEDGE: Basic operations of computer, Certificate in MS Office ( Good command over MS-Word, power point & Excel) PAPERS PRESENTED AT CONFERENCES Marketing Authorization Procedure & Requirements for registration of Pharmaceutical Products in Euro. Poster presented at at IPC-2015, Hyderabad PUBLISHED ARTICLES Drug Product Registration And Regulatory Requirements In Australia (TGA) Praveen Agarwal*, Mudit Dixit, STM Journals: 2015; Vol 2, N 1; 7-15 Approval Process Of Medical Device In Japan Praveen Agarwal*, Himanshu Joshi, International Conference at Teerthanker Mahaveer College of Pharmacy Moradabad (ACCEPTED) Improvement of the solubility and dissolution of Tolfenamic acid using Lyophilization technique Mudit Dixit, Praveen Agarwal, International Journal of Pharmaceutical Research and Bio-Science. 2014; Volume 3(6): 231-241 Preparation and characterization of Micro particles of Tenoxicam Mudit Dixit, Deepak Bhandary, Praveen Agarwal; International Journal of Pharmaceutical Research and Bio-Science. 2014; Volume 3(6): 221-230 CONFERENCES/SEMINARS ATTENDED Attended 66th Indian Pharmaceutical Congress held at Hitex, Hyderabad. Pharmaceutical drug registration procedure for Japan, at NGSM Institute of Pharmaceutical Science, 2013. The Happening emerging markets, a challenge to Pharma industry, at NGSM Institute of Pharmaceutical Science, 2014. The Drug Master File, at NGSM Institute of Pharmaceutical Science, 2014.
- 3. 3 STRENGTHS AND AREAS OF INTEREST Highly adjustable to any environment, Very supportive in group. Pre-planned goals and precise in doing work, Hard-working, detailed oriented and able to do multi task. Excellent collaboration, communication and presentation skills. Highly inquisitive, creative and resourceful and willingness to be a continuous learner My core areas of competence are product registration requirements for LATAM, INDIA & EU for both Pharmaceuticals and medical devices. Knowledge in Regulatory Guidelines like ICH, USFDA, TGA, EMA. Knowledge of eCTD, CTD, ACTD format and other ROW countries requirements as per respective MOH Fair understanding about Indian regulatory agency (DGCI) and state FDA QUALIFICATION UNIVERSITY YEAR AGGREGATE PERCENTAGES Masters in Pharmacy NITTE University, Mangalore 2015 71.2% Bachelors in Pharmacy NITTE University, Mangalore 2013 65.8% Intermediate Board of Intermediate education, U.P. 2009 62.4% S.S.C Central Board Of Secondary Education, Mangalore. 2006 48.8% DECLARATION I hereby declare that the above information furnished is true to the best of my knowledge and belief. Date: 13-05-2015 Place: Bangalore (Praveen Agarwal) PERSONAL DETAILS Date of Birth 23rd August, 1988 Gender Male Nationality Indian Marital Status Unmarried Languages Known English, Hindi, Kannada and Tulu. Current Address 200/38, Anjana Nilaya, Nanjappalayout, 2nd main 2nd cross. Opp - Adugodi Police Quarters. Adugodi 560030, Bengaluru Permanent address D/No- 59595, Sri Nagar House Alake, Opp - Suvarna Clinic Mangalore - 575003