Institute of Good Manufacturing Practices India
Global accredited training 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
Incorporated under Ministry of Corporate Affairs, Government of India
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD – Certificate of Merit 2015

Trusted by training participants in over 30 countries


CERTIFICATE PROGRAMME 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 around the world

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

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 a minimum of 1 and maximum of 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

A one-time fees (lump sum paid at beginning of the course) of Rs 7,500/- (300 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material examination fee etc.

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 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.

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.

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

[email protected]/+91 8130924488

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