Institute of Good Manufacturing Practices India®

Global accredited training & certification provider

IGMPI Approvals & Accreditation : 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)
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Certificate in Registration of Drug and Dossier Preparation (CTD and e CTD Submission)

This course takes through the essential steps for submitting electronic submission to the regulatory agencies and Research (CDER) and can serve as a resource for questions about the submission process. The eCTD format has become mandatory in key markets for electronic submissions. This course, while focusing on the US requirements, also provides a quick overview of current regulatory guidelines of eCTD in major world market including North America, the European Union etc. It aims to introduce tools to assist the participants in formulating effective strategies in the development, compilation, and submission of US-compliant eCTDs This course is designed for professionals of the biotechnology and pharmaceutical industries who are currently, or planning to become, involved in the development of regulatory submissions using the electronic Common Technical Document (eCTD). The program is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in Regulatory Affairs / Regulatory Operations, Submissions Management, Authors of CTD Sections, Technical and Clinical Writers, Documentation Teams, Project Management and Information Technology and Information Systems.


Module 1 :Market authorization & electronic submission in major markets

Module 2 :Registration of Drug and Dossier Preparation (CTD and e CTD submission)

Module 3 :Drug Registration, CTD and e CTD submission in India.

Module 4 :Industry specific case studies

Eligibility

Any Life Science graduate/ B.Pharm/M pharm/MSc/ 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 a minimum of 1 and maximum of 3 months.

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 recorded lectures on all key areas of the programme giving all flexibility to the participants.
  • 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.
  • 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.

    Examination & Certification

    IGMPI follows a credit system based on all 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 Registration of Drug and Dossier Preparation (CTD and eCTD submissions). 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 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

    This course provides a comprehensive description on the Common Technical Dossier structure - completely updated to reflect the latest changes in pharmaceutical regulatory affairs. After completion of this course, professional will be able to identify the recent requirements for developing drug substance and drug products and setting up a registration dossier.


    Programme Fee Details

    How to apply

    For further enquiries, write to or call us on::
    info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280

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    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like