Certificate in Biological Product Registration

Certificate in Biological Product Registration (CBPR)

Biological productscomprises of vaccines, blood and blood components, allergenic goods, somatic cells, gene therapy, monoclonal antibodies, recombinant therapeutic proteins, and cellular and gene therapy products are just a few examples of the many products that fall under the category. Depending on the type of product, the regulatory requirements for biological goods might be extremely complex. Biosimilar products are capable of receiving regulatory approval and going into clinical use as patents for licensed biologic (originator) products that are currently on the market expire. Biosimilar are highly similar duplicates of the original biologics that have been subjected to thorough analytical, non-clinical, and clinical studies before being licensed through defined and severe regulatory processes. The regulatory frameworks for later entry biologics and biosimilar goods are being established separately.

This programme targets the training needs of executives who are or will be involved in the preparation of development plans and registration of dossiers. This certificate programme develops understanding the Regulatory framework and evaluating the requirements of each subcategory of a biological product in the majorand RoW markets. Which is a challenging task and demands complete knowledge of the product and country-specific Regulatory information. This programme will provide benefit in terms of:

Knowledge in biologics and biosimilars

Biological product registrationin major markets (e.g., US, EU, Japan, and Australia)

Biological product registration in RoW market (Asia, Africa, Latin America, GCC, & CIS regions)

Biological product registration in India

Each type of biological/biosimilar product has different regulatory needs, and the submission guidelines are constantly changing

Regulatory strategy for biological products and biosimilars. This includes knowledge of clinical trials in specific regions, stepwise approach for product registration in multiple countries, and strategic approach in Regulatory submissions

Drug development strategy for biosimilars. This includes identification of reference medicinal product, demonstration of analytical similarity, clinical data waivers, reducing the need for clinical data generation on local population.

Dossier preparation in country-specific formats.Submission for biological products CMC variations/amendments/supplements to different Health Authorities

Biological product lifecycle management and renewals

Programme Modules

Module 1: Introduction to Biologics and Biosimilars
Module 2: Drug Development Process for Biologics and Biosimilars
Module 3: Biological product registration in major markets (e.g., US, EU, Japan, and Australia)
Module 4: Biological product registration in RoW market (Asia, Africa, Latin America, GCC, & CIS regions)
Module 5: Biological product registration in India
Module 6: Dossier preparation in CTD format, eCTD submissions for Biologics and Biosimilars
Module 7: 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 Biological Product Registration 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 leading biotechnology companieslike Serum Institute Of India, Panacea Biotech Ltd., Bharat Serums and Vaccines Limited, Biocon Ltd, Novozymes South Asia, Wockhardt Ltd, Novo Nordisk and Serum Institute of India. These biotechnology firms have devised ways to provide an essential backbone for the country's economy. Many Pharmaceutical companies are expanding their portfolios in biologics such as 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 and Lupin.

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 Biotechnological, Pharmaceutical and Healthcare industries on regular basis.

Future career prospects

The objective of these programs 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, specifically registration and documentation of biologicalsfor global and emerging markets should attend this programme. These programs are highly recommended for those who are aspiring to move into regulatory affairs from other areas within pharmaceutical and biotechnologycompanies.

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