A regulatory affair is important but at the same time most dynamic job area in the pharma and healthcare industry. The department of regulatory affairs is incessantly growing and evolving and is the one which is least affected during recession. It ensures the compliance of a company with all the government laws and regulations concerning their business. Each new case, new invention, new process and new need marks the change of some old regulation and even advent of some new ones. The category wise description is huge, taking into glance the product divisions, manufacturing processes, techniques and activities involved in healthcare product manufacturing and each category has a set of individual regulations to abide by along with the common rules, applicable to all classes of products and industries.
In this scenario, the huge knowledge base with added fringe of its dynamicity makes learning an ongoing and essential feature for anybody targeting to sustain and grow in the industry. Post Graduate Diploma course does the same by familiarizing the participant to the:
- Basics of the industry
- History of regulations and regulatory bodies
- On-going trends and guidelines for the varied sectors of the industry (drugs, food, beverages, biotech, cosmetics etc.)
- Change susceptible areas, compliance rules
- Inter-state deviations in rules and challenges of the industry.
The course is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Regulatory affairs as their career choice.
Module 1: Introduction to Global Regulatory Authorities for pharma and healthcare industries
Module 2: Drug Development Process, Clinical Trials and related norms and regulations
Module 3: GMP and other good practices (International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc)
Module 4: Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc.
Module 5: Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 6: Dossier preparation in CTD format, eCTD submissions
Module 7: Healthcare Industry IPR, Patents, copyrights and Trademarks
Module 8: Pharma and Healthcare products- Marketing, Import and Export regulations
Module 9: Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach reports
Module 10: Indian GMP Regulations
Module 11: Drug Registration in African Countries.
Module 12: Drug Registration in Gulf (GCC) Countries.
Module 13: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)
Module 14: Industry specific case studies
- ANDA, NDA, INDA filing
- Drug development process and its filing
- Conventional dossier preparation
- Preparation and filing of DMF
- Preparation of CTD/eCTD dossiers for submission in regulatory agency
- Preparation of clinical trial protocols and final clinical trial reports
- Preparation of an IMPD for EU submission
- Regulations in different countries and its filing process
- Filing and preparation of Indian patent as per regulatory perspective
- Preparation of GMP compliance checklist
- Documentation for inspections and audits
After completion of the course, participant is expected to have in-depth knowledge and up-to-date understanding of concept of generic drug and innovator, drug discovery and development, Regulatory strategy, approval process of all regulatory filings in various countries, filing process of IND, NDA and ANDA, IMPD, and Investigator Brochure (IB), DMF, US Hatch Waxman Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bio equivalence and drug product assessment-in vivo, Manufacturing and Controls (CMC) and their regulatory importance, Submission of global documents (CTD/eCTD), Filing process in India-IND, NDA, Clinical trials (Schedule Y) etc. The post graduate diploma in quality assurance and quality control offers the combined knowledge of theoretical and practical knowledge in all areas that affects the drug quality. It also provides the working knowledge of various analytical instrumental techniques, method development, documentation, protocol and SOP writing etc.
The course is designed in such a way to provide industrial level education regarding the applicable laws and regulations. It focuses on laws and regulations which a healthcare industry must comply to sell their product effectively in the market. The course also provides the knowledge of filling of information regarding new drug development, manufacture, control, stability studies, packaging, labeling etc. with regulatory agencies in a prescribed format.
All those who have completed their Graduation or Post Graduation are eligible to enroll for the course. As this course is truly professional and industry oriented, experienced individuals worked in any sector (production, processing, quality, trial, R&D etc.) in the healthcare industry (Food manufacturing, Food Ingredient and Additive processing, Drugs manufacturing , Medical Device, Ayurvedic, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurvedic Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology) can also seek benefits of the course.
Programme duration is 12 months.
The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty.. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.
All the efforts will be made in the form of 3 months internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.
IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.
All the participants are obliged to appear for annual exam at the end of the course. After successful completion, the participants will be awarded Post Graduate Diploma in Pharmaceutical Regulatory Affairs by Faculty of Good Manufacturing Practice, IGMPI. For all the above mentioned modules elaborate course material and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, PepsiCo India, Mankind, Beryl Drugs, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.
IGMPIs course is a professional course targeted to cater the industry needs trained regulatory affair professionals. The information, guidance, practical training and off course completion certificate will provide the participant with not one but many opportunities in the industry. this would come true in form of job roles and positions like that of Regulatory affair auditor or personnel in reputed pharmaceutical companies, cosmetic manufacturing units, Food and Food supplement manufacturers, biotechnology companies and many alike.
Apart from this, the industry needs experienced and learned regulatory affair officers for Govt. compliance issues, product registration and approval issues, process documentation etc. Also, Govt. sector has upcoming need for RA professionals to assist as officers and audit inspectors.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like