Institute of Good Manufacturing Practices India
Global accredited training & certification provider
Approved by Quality Council Of India (QCI), Government of India
Accredited Vocational Institution of Ministry of HRD, Government of India
An ISO 9001:2008 Certified Organisation
Registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
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

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Certified Drug Regulatory Affairs Professional

IGMPI has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The certification would impart among the candidates the ability to examine specific regulations that governs the Pharma industry in USA, Europe, UK, Canada, Japan, India etc. The curriculum of the certification is designed as a comparative analysis of Pharma regulatory systems of different nations integrated with concrete management tools of the supply chain like, Certification schemes, Regulatory compliance with government guidelines, product approval procedures etc. To obtain the certification, candidate must clear the qualifying exam for which proper training materials will be provided by the institute. No extra charges will be applied for this material.

Our training for the preparation of this certification is aimed at improving the conceptual knowledge of the participant towards formation of efficient public policies, compliance with regulatory guidelines, the regulatory strategies of companies in the food industry, and resolving any dilemmas that a working professional may face at respective workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study resources have been carefully designed to introduce the participant to various aspects and basics of industrial applications, its need, and benefits in assuring quality production.

The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified Drug Regulatory Affairs Professional in the domain. An advanced training having rigorous case studies based methodology will be imparted to all participants to prepare for the Certifying Examination. The training in Regulatory Affairs imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

Certified Study Resources


• Regulatory Authorities around the world
• Various stages in Drug development
• Introduction to the GMP concept
• Methodological regulatory filing around the world
• Common Technical Document Filing. eCTD submission process
• Intellectual Property Rights in Pharma Industry
• Quality Assurance and Drug Regulations, ICH and WHO guidelines
• Guidelines for Import and Export of Pharma products
• Audits by the Government and Regulatory bodies
• Breach reports and Compliance guidelines
• Industry specific case studies

Eligibility

The participants must have three years of on-the-job experience in any of related areas. Any Life Science graduate/ B.Pharm/M pharm/MSc/Phd in science disciplines/ any diploma /degree holders, 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 as long as they have the required three years of on-the-job experience . Those who have completed their post graduation will need to have 2 years of on-the-job experience and those who have completed their PhD will need to have 1 year of on-the-job experience. Selection will be based on the participant’s profile. IGMPI reserves the right to reject any application with full fee refund.

Registration

The registration dates for this certification run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the certification lectures, videos and study material easily accessible. This gives huge window of self regulated and self-paced performance to the participants. After registration confirmation by the institute, required study resources, assessment test papers will be dispatched to the participants. This study material is considered sufficient for the preparation of the certification exam. However, the participants should feel free to go through other study resources and resources as well. The certification examination will be notified after 2 months of the registration.

Certification and Membership Fees

Rs. 18000/- for Indian nationals and 500 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500/-( USD 125 for overseas) is optional to pay in order to avail the services of Certified Study Resources and training for the preparation of the certification exam.

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as Drug Regulatory Affairs Professional by IGMPI. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.

Re- Examination

In case the participant is not able to pass the certification exam in first attempt/exam notification, he/she will have to re- register for the next scheduled examination by submitting re- registration form along with the re- registration fee of Rs. 1500/-(50 USD) . However, the participants will be given sufficient flexibility in scheduling their “First” certification exam.

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 Professionals 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.

How to apply

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

[email protected]/+91 8130924488

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