This programme provides a comprehensive description and discussion of the regulatory environment. The Comprehensive Training on European Regulatory Affairs including different Registration Procedures and Variations. This is a unique opportunity to learn, understand and discuss the main aspects of drug regulations in Europe directly from key European Regulators and from the large experience in the pharmaceutical industry and to acquire key recommendations for a successful implementation of regulatory strategy and operations.

Programme Modules

Module 1 : Marketing Authorization Application (MAA) in EU

Module 2 : Types of Submissions (New MAA, Variation, Extension, Renewals, PSUR, PSUA, ASMF, PMF, etc.)

Module 3 : Comparison of Drug Approval Process in US and Europe

Module 4 : eCTDEU Module 1 Specifications (Envelope, Cover letter, Administrative and Prescribing Information, Labelling, etc.) (eCTD v3.0.4)

Module 5 : eCTD EU Module 2, Module 3, Module 4, Module 5 Specifications (eCTD v3.2.2)

Module 6 : Dossier preparation in CTD Format, eCTD Submissions

Module 7 : Industry specific case studies

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

Minimum duration to complete this programme is 3 months and maximum is 6 months.

Programme Mode

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

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 expected to appear for online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in Drug Registration (European market) by IGMPI. For all the above mentioned modules elaborate course material, assignment and case studies 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. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects

The objective of these courses is to impart knowledge and practical understanding about the drug registration procedures that are available and the structure of the registration dossier. Professionals who are willing to have a successful career in regulatory affairs, registration and documentation for European Countries, GCC Countries, India, US market should attend this course. These courses are highly recommended for those who are aspiring to move into regulatory affairs from other areas within a pharmaceutical company.

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Programme Fee Details

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free),  Phone: +91 11 26512850

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