Institute of Good Manufacturing Practices India
Global accredited training & certification provider
Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
Approved Training Partner of Food Safety and Standards Authority of India (FSSAI)
An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

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Executive Diploma in  Pharmaceutical Regulatory Affairs(QCI, Government of India Approved & Certified)

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.

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 with limited time brackets but 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 earned in less time;

• Recognised diploma certificates indicating candidate proficiency in the subject;

• Practical knowledge making industry ready professionals;

• E/distance course offering convenience of attaining knowledge at self driven pace;

• Excellent e-tools which make the course even more interactive and easy to access.

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: Indian GMP Regulations

Module 11: 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, 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 case study based approach in Executive Diploma programme via distance cum e learning mode is designed for working professionals in full-time employment who wish to complete the course in shorter time duration. This course is beneficial for professionals from different streams to help them intensify their knowledge. This is a fast track and advanced course having rigorous case studies based methodology throughout the duration.

Eligibility

All those who have completed their Graduation or Post Graduation/ Pharm D / PhD are eligible to enroll 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.

Programme Duration

Minimum time in which a student can complete this diploma course is 6 months while a maximum of 12 months is allowed to complete the course.

Registration

The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are strictly scheduled depending on the availability of speakers. 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.

Programme Fee

A one-time fees (lump sum paid at beginning of the course) of Rs 22,000 /- (600 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material fees ect. Apart from this, an examination fee of Rs 400/- (USD 15) per module needs to be paid later as per the examination notification of the Institute.

Examination & Certification

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 Executive Diploma in Pharmaceutical Regulatory Affairs. 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.

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 e/distance 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.

How to apply

For further enquiries or Prospectus, write to or call us on:

[email protected]/+91 8130924488, +91 8587838177, 0120-4375280

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