A regulatory affair is important but at the same time most dynamic job area in the healthcare industry. Each new case, new invention, new process and new need marks the change of some old regulation and even advent of some new ones. The category wise description is huge, taking into glance the product divisions, manufacturing processes, techniques and activities involved in healthcare product manufacturing and each category has a set of individual regulations to abide by along with the common rules, applicable to all classes of products and industries.

In this scenario, the huge knowledge base with added fringe of its dynamicity makes learning an on-going and essential feature for anybody targeting to sustain and grow in the industry. Post graduate Diploma/Executive Diploma/Industry Certification programmes does the same by familiarising the participant to the:

- Basics of the industry;
- History of regulations and regulatory bodies;
- On-going trends and guidelines for the varied sectors of the industry (drugs, food, beverages, biotech, cosmetics etc.);
- Change susceptible areas, compliance rules;
- Inter-state deviations in rules and challenges of the industry.

The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Regulatory affairs as their career choice.

After completion of the programme, participant is expected to have in-depth knowledge and understanding of concept of generic drug and innovator, drug discovery and development , Regulatory strategy, approval process of all regulatory filings in various countries, filing process of IND, NDA and ANDA, IMPD, and Investigator Brochure (IB), DMF, US Hatch-Waxmn Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bioequivalence and drug product assessment-in vivo, Manufacturing and Controls (CMC) and their regulatory importance, Submission of global documents (CTD/eCTD), Filing process in India-IND, NDA, Clinical trials ( Schedule Y) etc.

Programme Modules

Module 1: Introduction to Global Regulatory Authorities in Pharmaceutical Industries 

• Drug Regulations
• Role of Regulatory Authorities
• Global Pharmaceutical Market
• Regulatory authorities in Regulated and Semi-regulated (RoW) market

Module 2: Drug Development Process

• Drug discovery
• Target Identification
• Lead Identification
• Lead Optimization
• Preclinical studies
• Phases in Clinical Trials

Module 3: Regulatory Toxicology

• Introduction to toxicology and related terminologies
• OECD Test Guidelines (Acute, Subacute, Sub chronic and Chronic); Oral, Dermal and Inhalational
• Genotoxicity
• Teratogenicity
• Reproductive Toxicology and Carcinogenicity

Module 4: GMP and other good practices 

• Principles of GMP
• Overview of National and International GMP Regulations; Pharmaceuticals, Biologicals, Herbals
• GMP Regulations for Regulated Markets: USA, EU, Japan, Canada, Australia, New Zealand, and Brazil
• GMP Regulations for Semi-regulated Markets: Gulf Countries, Africa, and India
• GLP, GDP, GCP, GAMP and GXP’s 

Module 5: Drug Approval and Review Process

• Drug approval and review process by global regulatory authorities
• Regulatory Submission Requirements of USFDA: IND, NDA, ANDA, BLA, DMF, PAS, CBE, Annual Reports, Supplement
• EU Market Authorisation Application (MAA) ,Variations, Renewal, Extension
• Drug Registration in; UK, Japan, Brazil, Canada, Australia, New Zealand, Latam countries and India

Module 6: ICH and WHO guidelines 

• International Council on Harmonisation (ICH)
• ICH Guidance on: Quality, Safety Efficacy and Multidisciplinary
• World Health Organisation (WHO)
• WHO Guidance on: GMP, GDP, GLP, GRP, GReP, and GXP’s
• WHO Regulations pertaining to quality control, quality assurance and manufacturing of finished pharmaceuticals, API, biologicals and herbals.

Module 7: Dossier preparation in CTD format, eCTD submissions

• ICH CTD Module
• eCTD
• NeeS
• Dossier Compilation Requirements
• Dossier Publication and Submission 

Module 8: Pharmaceutical Industry IPR

• Intellectual Property Rights
• Patents
• Trademark
• Copyright 

Module 9: Pharmaceutical- Marketing, Import and Export regulations 

• Pharmaceutical Product Promotion Activities
• Regulations pertaining to Pharmaceutical Product Promotion Activities: USFDA, EMA, ANVISA,
• Import and Export Regulations
• Import and Export licenses, forms and approvals; USFDA, EMA, TGA, UK MHRA, ANVISA, CDSCO, GCC, and Africa

Module 10: Compliance guidelines, Regulatory Audits and Breach reports

• Types of Audits and Inspections
• Regulatory Audits (FDA, MHRA, PMDA, TGA, DCGI)
• Audit Observations, Response letters, Warning letters, Revocation of GMP license
• Breach Reports 

Module 11: Indian GMP Regulations

• Introduction to Drugs and Cosmetics Act, 1940
• GMP: Schedule M Requirements
• Requirements for procuring GMP license; forms, procedures, inspections
• Import and Export requirements
• WHO-CoPP

Module 12: Drug Registration in African Countries 

• NMRA’s in African Countries
• Drug Approval and Review Process in African Countries
• GMP Requirements: WHO, license, forms, procedures, inspection
• Dossier compilation and submission requirements
• Import and Export requirements 

Module 13: Drug Registration in Gulf Countries

• Introduction to GCC
• Drug Approval and Review Process in GCC
• GMP Requirements: WHO, license, forms, procedures, inspection
• Dossier compilation and submission requirements
• Import and Export requirements

Module 14: AYUSH Regulatory Affairs 

• Introduction to Ministry of AYUSH (Ayurveda, Unani, Siddha, and Homeopathy)
• Product Development, Standardisation, Clinical Trials of traditional medicines; Pharmacopoeias and monographs
• Submission Requirements for AYUSH products in India
• GMP Requirements: Schedule M, Schedule T, WHO-GMP for herbal medicine, GMP license, CoPP
• Regulatory requirements of traditional medicines by USFDA, Health Canada, EMA, and TGA

Module 15: Industry Based 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

The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).

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 obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Post graduate Diploma/Executive Diploma in Pharmaceutical Regulatory Affairs by Faculty of Good Manufacturing Practice, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. 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 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 like IQVIA, Syneos Health, Fisher Clinical Services, Astron Research, Divi’s Laboratories Limited, Navitas Life Sciences, Torrent Pharmaceutical Ltd., Cipla Limited, Emcure Pharmaceuticals, Sun Pharmaceutical Limited, Mankind Pharma, Ajanta Pharma, IPCA Laboratories, 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 of Pharmaceutical Regulatory affairs Training

IGMPIs online programme is a professional programme targeted to cater the industry needs trained regulatory affair professionals. The information, guidance, practical training and off programme completion certificate will provide the participant with not one but many opportunities in the industry. this would come true in form of job roles and positions like that of Regulatory affair auditor or personnel in reputed pharmaceutical companies, cosmetic manufacturing units, Food and Food supplement manufacturers, biotechnology companies and many alike. Apart from this, the industry needs experienced and learned regulatory affair officers for Govt. compliance issues, product registration and approval issues, process documentation etc. Also, Govt. sector has upcoming need for RA professionals to assist as officers and audit inspectors.

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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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