Executive Diploma in Regulatory Affairs (Six Months Part Time : QCI, Government of India Approved & Certified)
The Executive course has been designed keeping in mind the zest and vigour in industry employees to know and get trained in regulatory affairs. Also, it caters to needs of those who desire to change their current work profiles to regulatory officers or to shift to Govt. healthcare authorities as regulatory affairs inspectors, associates or auditors.
The executive course in regulatory affairs offers many benefits in terms of:
• Comprehensive knowledge and training
• Recognized diploma certificates indicating candidate proficiency in the subject
• Practical knowledge making industry ready professionals
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
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: 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 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 working in the Pharmaceutical Industry or any sector of Healthcare industry or any other industry type (India) can apply for this part time programme. Life Science graduate/ B.Pharm/M.pharm/MSc/PhD in science disciplines/ or passed outs of Clinical Research degree or diploma courses are also eligible for the course. Working professionals of any of the following industry types 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 or any related industry are highly encouraged to apply for the programme.
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 6 weeks 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.
A one-time annual programme fees (lump sum paid at beginning of the course) of Rs. 60,000/-(1,500 USD for overseas students) which can be paid in installments. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, every student has to pay an examination fee of Rs 400/-(15 USD for overseas students) per module as per the examination notification of the Institute.
Examination & Certification
All the participants are obliged to appear for this exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Regulatory Affairs. 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.
Placement Assistance & Corporate Relations
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.
Future and career prospects in Regulatory affairs
The highly regulated healthcare industry offers tremendous job prospects. IGMPI’s course is a professional course targeted to cater the industry needs trained regulatory affair professionals. The information, guidance, practical training and 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.
For further enquiries or Prospectus, write to or call us on:
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