Certificate in DRUG REGISTRATION (US MARKET-ANDA, NDA etc.)

Certificate in Drug Registration (US MARKET-ANDA, NDA etc.)

This programme targets the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers. Tougher regulatory approval processes pose challenges for pharmaceutical companies registering drugs in the USA. This certificate programme develops understanding of all the current procedures in the challenging environment of US. By attending this 1 month programme, practical insight will be gained into FDA's requirements for new drug development and preparation of new drug registration dossier accordingly to US guidelines. This programme will provide benefit in terms of:

Faster drug registration in the US.

Needs, expectations and regulatory requirements of the FDA for the drug registration dossier

Preparation of successful Investigational New Drug Applications (INDs) & New Drug Applications

(NDAs)

Programme Modules

Module 1 : Drug Approval Process in USA

Module 2 : Types of Submissions (Original, Supplement, PSUR, PADER, REMS, DMF, etc.)

Module 3 : Drug Application Process of IND

Module 4 : Drug Application Process of NDA

Module 5 : Drug Application Process of ANDA

Module 6 : Drug Application Process of BLA

Module 7 : Drug Application Process of Nonprescription Drugs

Module 8 : eCTD Module 1 Region Specific Requirements (Cover letter, Labelling, etc.) (eCTD v3.3)

Module 9 : eCTD Module 2, Module 3, Module 4 and Module 5 Specifications (eCTD v3.2.2)

Module 10 : Dossier preparation in CTD Format and eCTD Submissions

Module 11 : Industry specific case studies

Eligibility

Any graduation/ 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.

Programme Duration

Minimum duration to complete this programme is 3 months and maximum is 6 months.

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.

– 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.

Examination & Certification

IGMPI follows a credit system based on 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 Drug Registration (US Market-ANDA,NDA etc.) by IGMPI. For all the above mentioned modules elaborate programme 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 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.

Future career prospects

The objective of these programmes 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 programme. These programmes are highly recommended for those who are aspiring to move into regulatory affairs from other areas within a pharmaceutical company.

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