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Regulatory Affairs

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REGULATORY COMPLIANCES AND AFFAIRS

Course Overview

Regulatory affairs is a field that focuses on the regulations and guidelines governing the development, approval, and marketing of pharmaceuticals, medical devices, and other healthcare products. In this course, you will learn about the regulatory framework and processes involved in bringing these products to market.

The course covers a wide range of topics, including:


  • 1- Regulatory strategies: You will gain an understanding of the strategies and considerations involved in navigating regulatory requirements, ensuring compliance, and achieving successful product approvals.
  • 2-Regulatory submissions: You will learn how to prepare and submit regulatory documents, such as investigational new drug applications (INDs), new drug applications (NDAs), and marketing authorization applications (MAAs).
  • 3-Quality and compliance: The course will cover quality management systems, good manufacturing practices (GMP), and other quality and compliance aspects necessary for regulatory approval.
  • 4-Post-market surveillance: You will explore post-market requirements, including adverse event reporting, labeling updates, and post-approval commitments.
  • 5-International regulations: The course will provide an overview of global regulatory frameworks, including the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and other regulatory agencies.

“We Prepare Tomorrow’s Leaders for a Profession with Endless Potential”

Course Objectives

The courses will provide integrated knowledge and broad perspectives you need to effectively manage the regulatory process from Innovation →Discovery → Approval→ Commercialization which implies regulatory affairs are essential to bring the product to the market globally.


  • To gain the essential knowledge and skills required to help companies to work in regulatory environment.
  • Acquire the foundation to work within or in variety of areas including medical products development, pharmaceutical formulations, sales, strategic marketing and clinical investigations.
  • To know about regulatory process in drug development, formulations, API.
  • To sharpen the understanding of the laws that governs the development, manufacturing and commercialization along with the distribution of drugs, biologics and medical devices.

Value

  • Understand Regulatory Concepts
  • Able to write and review Regulatory Documents
  • Submission of Dossiers, DMF, e-CTD etc.
  • Marketing Authorization and Regulatory Compliance Systems of different countries
  • Approval Process
  • Gain advanced tools necessary to optimize and maintain your regulatory procedures
  • Obtain the knowledge necessary to keep up to date with new legislation in a constantly changing environment
  • Preparation for audits and inspections
  • Advance to an higher level in RA career ladder
  • Become an RA professional or Technically expertise Regulatory Professional in Totality

Advantages of IBRI Courses

IBRI course is different from other institutes and universities as its study material is based on recent trends and includes following topics:


  • Procedure for the documents submission e.g. DMF, CTD/E-CTD, Dossier
  • Loan License ( Contract Manufacturer)
  • Hatch Waxmann Act; Bolar Provisions
  • Separate Description of Regulations for Biologics, Medical Device/Pharmaceutics
  • Recently globally included of regulations and Compliance systems of Australia, Brazil, GCC,TGA etc.
  • Biopharmaceuticals
  • Market Authorization, Audits and inspections.

Career Opportunities in Regulatory Affairs

There are various career opportunities in regulatory affairs! Some of the roles you can pursue include:
Regulatory Affairs Specialist: As a specialist, you will be responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and coordinating with regulatory agencies.
Regulatory Affairs Manager: In this role, you will oversee regulatory affairs activities, manage a team of specialists, and develop strategies to navigate regulatory challenges.
Regulatory Compliance Officer: This position involves ensuring that companies adhere to regulatory standards, conducting audits, and implementing compliance programs.
Clinical Regulatory Affairs Associate: If you're interested in clinical research, this role involves managing regulatory aspects of clinical trials, preparing and submitting clinical trial applications, and ensuring compliance with regulatory guidelines.
Regulatory Affairs Consultant: As a consultant, you can provide expert advice and guidance to companies in navigating regulatory requirements, developing strategies, and preparing regulatory submissions.
Quality Assurance/Quality Control Specialist: This role involves ensuring that products meet regulatory and quality standards, conducting audits, and implementing quality management systems. These are just a few examples, and the field of regulatory affairs offers diverse opportunities in pharmaceuticals, medical devices, biotechnology, and other healthcare sectors. It's an exciting field that combines scientific knowledge with regulatory expertise.


Eligibility

Candidates with MBBS / B.D.S / B.A.M.S / B.H.M.S /B. Pharmacy / BVSC/ B.Sc. (Nursing)/ M.Pharma are eligible. Educational qualification and experience in the field of medical sciences, life sciences, data management, and clinical research. Even B,Sc life sciences or B.Tech in Biotech are eligible for the course.


Type of companies hiring RA professionals

  • Pharmaceutical
  • Medical Devices
  • In Vitro Diagnostics
  • Biologics and Biotechnology
  • Veterinary Products
  • Cosmetics
  • Local FDA/ US FDA/UK MHRA/EDQM
  • Ministry of Health/DCGI
  • Clinical Research Organization/ Contract Research Organization
  • Pharmaceutical consultancy companies

RA Professional can get Employment as


  • Regulatory Affairs Associates
  • Regulatory Affairs Assistance
  • Regulatory Affairs Head/ Director
  • Medical Information Associates
  • Drug Inspector/Drug Controlle
  • Drug Safety Specialist/ Regulatory Food Safety Scientist
  • Quality Operations/Quality Control/Quality Assurance

“The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.”

Payment of Fees Details

Course fees can be paid by Demand Draft drawn in the favour of

“IBRI-UNIT OF EXORDIOR TECHNICAL SERVICES PRIVATE LIMITED” payable at “NOIDA”.


OR

Dispatch Address

To,
The Program Coordinator,
Indian Biological Sciences and Research Institute,
C-50, Second Floor, Sector-2, Noida-201301 (India)

Assessment and Certification

Course Methodology After the Enrollment the student will be provided study material in form of books, power points i.e. Introduction Kit is delivered to participants of the program – this kit will contain study material and all necessary information about the program with important dates.
Evaluation will be examination/assignment based Successful students will be awarded ‘Certificates’ in the respective areas by Distance participation along with the grade obtained.

Note: 1-Exam fees are excluded from Course fees.
2-Course fees can be paid by Demand Draft(DD) / At Par Cheque / Cash in favor of "IBRI-UNIT OF EXORDIOR TECHNICAL SERVICES PRIVATE LIMITED" payable at "NOIDA".