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

Module 1: Regulatory Authorities around the world
Module 2: Various stages in Drug development
Module 3: Introduction to the GMP concept
Module 4: Methodological regulatory filing around the world
Module 5: Common Technical Document Filing. eCTD submission process
Module 6: Intellectual Property Rights in Pharma Industry
Module 7: Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 8: Guidelines for Import and Export of Pharma products
Module 9: Audits by the Government and Regulatory bodies
Module 10: Breach reports and Compliance guidelines
Module 11: Drug Registration in African Countries.
Module 12: Drug Registration in Gulf (GCC) Countries.
Module 13: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)
Module 14: Industry specific case studies

Eligibility

Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

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.

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.

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.

View Prospectus

Programme Fee Details

How to apply

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