FDA considers master files to be submissions to an NDA, ANDA, BLA, or investigational new drug application (IND). These include new drug master files (DMFs), new biological product files (BPFs), and any amendments to or annual reports on previously submitted DMFs or BPFs. Active Substance Master File (ASMF) for drugs and Plasma Mater Files (PMF) for biologics is required for EU and RoW submissions. A DMF and ASMF may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

This programme is designed for professionals to provide an understanding of the role DMF and ASMF play in the regulatory approval process for drugs and biologics in US and EU. This programme will explain step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. This will be of great benefit to regulatory compliance professionals working on DMF, BPF, ASMF, PMF, NDA, IND or ANDAs, as regulatory affairs professionals, attorneys, project managers, and management professionals in small and midsize manufacture operations.

The requirement to submit DMFs using the eCTD format is part of FDA’s overall effort to review drug applications more efficiently. eCTD standardizes how industry submits applications, amendments, supplements, and reports. Implementing electronic DMFs improves the standardization of the DMF review process.

Learning Outcomes:

• DMF (Drug Master File) and BPF (Biological Product File) submissions for USFDA
• Convert paper DMF format to eCTD Format
• Active Substance Master File(ASMF) and Plasma Master File (PMF)Submissions in EU
• Overview of ASMF and PMF in semi regulated markets

Programme Modules

Module 1 : Drug development process and regulatory filings

Module 2 : Introduction to Drug Master Files and its Types

Module 3 : Preparation and Submission of Drug Master File

Module 4 : DMF and BPF in eCTD format (USFDA)

Module 5 : ASMF and PMF in eCTD format (EU)

Module 6 : ASMF and PMF in RoW market (GCC, Africa, etc.)

Module 7 : Industry specific case studies

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

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

Programme Mode

Registrations are currently open for regular and online both modes.

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.

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 Preparation and Submission of Drug Master File (DMF) 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 DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. Attendees will learn the differences between the five types of DMFs and the detailed information required within each type of DMF. Using a series of case studies, the programme will highlight real word examples and actual experiences with FDA submissions related to DMF components. Upon completion of the programme, attendees will be able to begin developing or to improve upon their DMF file documentation. Professionals working in manufacturing, Regulatory affairs, research and development, QA and QC, validation and development and preparation of submission material will be highly benefited by this programme.

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Programme Fee Details

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

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