A regulatory affair is important but at the same time most dynamic job area in the healthcare industry. 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 on-going and essential feature for anybody targeting to sustain and grow in the industry. Post Graduate Diploma course does the same by familiarising 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
After completion of the course, participant is expected to have in-depth knowledge and 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-Waxmn Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bioequivalence 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
All those who have completed their Graduation or Post Graduation/ Pharma are eligible to enrol for the course. As this course is truly professional and industry oriented, employed individuals working 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, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology) can also seek benefits of the course.
Minimum time in which a student can complete this diploma course is one year while a maximum of two consecutive years is allowed to complete the course.
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.
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 timely submit completed assessment assignments (during the course, usually after every module) and appear for an online 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, self-assessment assignments 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, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc.
IGMPIs e/distance 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