Institute of Good Manufacturing Practices India

  • 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 Institute of Food Safety and Standards Authority of India (FSSAI)
  • Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
  • 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 and Food Industry Sector Skills Council (SSC) 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

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research


CERTIFICATE PROGRAMME IN  DRUG REGISTRATION (EUROPEAN MARKET)

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.

Module 1 :Drug Registration in Europe

Module 2 :Comparison of Drug Approval Process in US and Europe

Module 3 :Dossier preparation in CTD Format, eCTD Submissions

Eligibility

Any Life Science graduate/ B.Pharm/M pharm/MSc/Phd in science disciplines/ any diploma holder or passed outs of Clinical Research degree or diploma courses are eligible for these course. Working professionals of any of the following industry types Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.

Programme Duration

The candidate is expected to complete the course in 3 months.

Registration

The registration dates for this programme run by the institute are updated timely on the webpage. 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.

Programmes Fees

The mandatory course fee (one-time payment) for the distance cum e learning mode is Rs. 14,500/- (400 USD for overseas students). This covers for the course registration fees, tuition fees, course material fees etc. 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 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). 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.

Corporate Relations

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. 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 and Food 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.

How to apply

For further enquiries or Prospectus, write to or call us on:
info@igmpiindia.org/+91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280
(10 AM IST to 5.30 PM IST)

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