Institute of Good Manufacturing Practices India®

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Executive Diploma in Pharmaceutical Regulatory Affairs


The Executive course has been designed keeping in mind the zest and vigour in industry employees to know and get trained in regulatory affairs. Also, it caters to needs of those who desire to change their current work profiles to regulatory officers or to shift to Govt. healthcare authorities as regulatory affairs inspectors, associates or auditors.

The Executive Diploma course targets to benefit such prospective candidates especially those targeting to harness benefits of being part of the much regarded and most important part of the healthcare industry- the quality assurance and quality control division. With the knowledge of healthcare industry and its norms and working models it becomes easier for a candidate to grasp and adjust to delicacy and heavy responsibility of the role of quality inspector. Thus, the executive diploma programme has been launched keeping eye on the goal of preparing and making ready experienced professionals from the industry which after attending the course will have better and clearer view of the quality testing methods, tools and fixing techniques. This specially benefits the employed participants of the course.

The executive course in regulatory affairs offers many benefits in terms of:

  • Comprehensive knowledge and training.
  • Recognized diploma certificates indicating candidate proficiency in the subject.
  • Practical knowledge making industry ready professionals.
  • Course Modules :

    Module 1: Introduction to Global Regulatory Authorities for pharma and healthcare industries.

    Module 2: Drug Development Process, Clinical Trials and related norms and regulations.

    Module 3: GMP and other good practices (International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc).

    Module 4: Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc.

    Module 5: Quality Assurance and Drug Regulations, ICH and WHO guidelines.

    Module 6: Dossier preparation in CTD format, eCTD submissions.

    Module 7: Healthcare Industry IPR, Patents, copyrights and Trademarks.

    Module 8: Pharma and Healthcare products- Marketing, Import and Export regulations.

    Module 9: Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach reports.

    Module 10: Indian GMP Regulations.

    Module 11: Drug Registration in African Countries.

    Module 12: Drug Registration in Gulf (GCC) Countries.

    Module 13: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy).

    Module 14: Industry specific case studies.

    Experimental Training

    - ANDA, NDA, INDA filing.
    - Drug development process and its filing.
    - Conventional dossier preparation.
    - Preparation and filing of DMF.
    - Preparation of CTD/eCTD dossiers for submission in regulatory agency.
    - Preparation of clinical trial protocols and final clinical trial reports.
    - Preparation of an IMPD for EU submission.
    - Regulations in different countries and its filing process.
    - Filing and preparation of Indian patent as per regulatory perspective.
    - Preparation of GMP compliance checklist.
    - Documentation for inspections and audits.

    After completion of the course, participant is expected to have in-depth knowledge and up-to-date 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 Waxman Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bio equivalence 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.

    The course is designed in such a way to provide industrial level education regarding the applicable laws and regulations. It focuses on laws and regulations which a healthcare industry must comply to sell their product effectively in the market. The course also provides the knowledge of filling of information regarding new drug development, manufacture, control, stability studies, packaging, labeling etc. with regulatory agencies in a prescribed format.

    Eligibility

    All those working in the Pharmaceutical Industry or any sector of Healthcare industry or any other industry type (India) can apply for this short term programme. Life Science graduate/ B.Pharm/M pharm/MSc/ students pursuing or passed outs of Clinical Research degree or diploma courses are also eligible for the course. Working professionals of any of the following industry types Food manufacturing, Food Ingredient and Additive processing, 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 programme duraion is 6 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 bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty.. 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.

    Internship

    All the efforts will be made in the form of 3 months internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.

    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 appear for annual exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Pharmaceutical Regulatory Affairs For all the above mentioned modules elaborate course material and project work details 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. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.

    The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

    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, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, PepsiCo India, Mankind, Beryl Drugs, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.

    Future career prospects of Pharmaceutical Regulatory affairs

    The highly regulated healthcare industry offers tremendous job prospects. IGMPI’s course is a professional course targeted to cater the industry needs trained regulatory affair professionals. The information, guidance, practical training and course 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.


    Programme Fee Details

    How to apply

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

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