Regulatory Affairs (RA) act as an interface between the Pharmaceutical Industry and Regulatory Authorities across the world. Its function is to ensure that product, subject matter of marketing authorisation submission meet all the regulatory expectations about quality, purity, safety and efficacy. RA strategies play a very important role in the success of the business. In addition, it also confirms the appropriateness and accuracy of product information. Regulatory affairs in industry aim to protect human health, promote safety, efficacy and quality of food, drugs, nutraceuticals, herbal products and medical devices.

Regulatory affairs field is dynamic and ever changing; as observed globally there are continuous changes/ updates in GxPs and other regulatory policies by National, Regional and Global Regulatory Agencies. Successful companies always track regulatory changes and work on policies proactively to remain compliant. Regulatory affairs staff should be well qualified and experienced and have diverse knowledge about the regulations in relevance to Regulatory submissions, Technology transfer, Medical devices, Food, Nutraceuticals, Herbal, Biological, Clinical trials, Pharmacovigilance, Intellectual property rights, etc. There are few institutions offering regulatory affairs PG programs and many other mushrooming organizations providing regulatory affairs certification using limited or very scanty modules spread over 1 – 6 months. Currently there is a dearth of well-structured Regulatory Affairs educational programs in India to cover all the essential aspects of regulations.

Identifying the scenario of regulatory education in the country, Dr. Vishwanath Karad MIT World Peace University (MIT WPU) has introduced the Post Graduate Diploma in Regulatory Affairs (PGDRA) program in 2019. Currently the PGDRA program is 11 months, two semesters, part time online weekend program. The program is unique and provides intensive and extensive exposure and up-to-date knowledge through well-planned theory, practical and interactive sessions. eCTD software is used for regulatory filing; we provide eCTD based hands on training as part of a well-planned full-fledged two semester RA program covering all aspects of pharmaceutical and health care regulations. Theory and practicals covered by industry persons who are actively involved in day-to-day regulatory affairs activities of pharmaceutical and healthcare organisations operating locally and globally.

Students are made job ready within a year as they are trained by industry experts and are trained for eCTD software usages for various regulatory submissions (https://admissions.mitwpu.edu.in/pharm-diploma/).

Extensive regulatory coverage is achieved with meticulously planned subjects spread over two semesters. First semester offers three theories and one practical subject; theory subject offered for first sem. are i. Global Regulatory Affairs, ii. Regulatory Requirements Compliance and Submissions, iii. Regulatory Aspects of Drugs and Cosmetics and iv. Regulatory Affairs Practical I. Second semester also includes three theories and one practical subject. These subjects are i. Clinical Research Regulations, ii. Biologicals Medical Devices and IVD Regulations, iii. Regulatory Aspects of Herbals Nutraceuticals and Food and iv. Regulatory Affairs Practical II. Furthermore, in each semester RA students are assigned with seminars, individual and group projects for submissions as part of continuous assessment and ample opportunities for interaction with internal and visiting faculties provided to each candidate.

Eligibility:

Candidates completed B. Pharm., studying in M. Pharm and Life science graduates are eligible for admission to the program. People working in the pharmaceutical and healthcare industry and PhD scholars from any Pharmacy and Life Science stream are also eligible for the program.

Course Objective::

• To provide a thorough and up-to-date knowledge of various national, regional and global regulatory agencies, laws and regulations as they apply to various stages of development and commercialization of Pharmaceuticals, Biopharmaceuticals, Herbals, Food, Nutraceuticals, Natural Health Products and Medical Device and in vitro diagnostics.
• To prepare students for regulatory affairs positions in industries involved in manufacturing, sales and export of pharmaceuticals, health care products and medical devices.

Employment Opportunities and Placements:

The job opportunities are ample in pharmaceuticals manufacturing, sales, and export operations and also in biotech, veterinary, cosmetic, food and medical devices, Contract Research Organizations (CRO), etc. These professionals will find employment as Regulatory Affairs, Quality Assurance, Documentation Officers; Medical Information Associates, Regulatory Affairs Consultants for Pharmaceutical / Biotechnology Industry, Regulatory Food Safety Scientist, Pharmacovigilance Manager, Drug Safety Specialist etc. Placement assistance provided to successful candidates through our well-established placement cell.

One day regulatory affairs workshop on “Global Regulatory Affairs, Opportunities, Challenges and Career” by School of Pharmacy, MIT WPU on 8th Feb. 2020.

One-day regulatory affairs workshop on “Global Regulatory Affairs, Opportunities, Challenges and Career” was organized by school of pharmacy, Dr. Vishwanath Karad MIT World Peace University, Pune on 8th Feb. 2020. First year M. Pharm QA students take the lead to manage all activities of the day. Industry experts invited to make the workshop beneficial to 50 participants’ from industry and academics.

Following Eminent speakers were invited:

• Mr. Santosh Savarkar – Director, Samrsa Consultants, Pune.
• Mr. Dhaval Ghuge -Regulatory Affairs Lead, Medline Industries India Pvt. Ltd., Pune. 
• Dr. Roshan R. Kulkarni – Partner, Improva Herbal Products, Pune.
• Ms. Maya Singh, Samrsa Consultants, Mumbai

The workshop was organized with aim to provide information on the functional domains, scope of pharma regulatory affairs, and allied topics such as:

• Global regulatory affairs – Regulated, Emerging and Rest of The World Markets
• Understanding Compliance needs for GxPs, ICH Guidelines, Regulations & legal obligations
• Medical Device and In vitro Diagnostics (IVDs) Sector and Opportunities
• Herbal, Nutraceutical and Food Supplement Scope and Opportunities