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Regulatory Affairs

DRUG REGULATORY AFFAIRS

Course Overview

The pharmaceutical industry is financially strong and growing and developing rapidly. At all times, the industry needs to be able to recruit a sufficient number of professionals with a focused background in the new upcoming domains of pharmaceutical sciences apart from traditional pharmacy knowledge like regulatory affairs, clinical trials, pharmacovigilance etc. Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, cosmetics, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory Affairs is the area with a broad overview and the responsibility for collecting all data from the development processes and sending it to regulatory authorities where the trained people in regulatory affairs are required. The development of new drugs and medicinal products is a long and complicated process that starts with the glimmer of a new idea and ends with the effective marketing of a finished product i.e. the success is dependent on the approval by the authorities.

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. The most significant responsibility of a Regulatory professional in an export company is to get a product successfully registered and approved by the Health Agency of the country like FDA for USA or EMA for Europe. IBRI offer regulatory affairs by online as well as by distance mode with recent study materials. The course has been designed keeping in mind the zest and vigour in industry employees to know and get trained in regulatory affairs. This course is beneficial for professionals from different streams to help them intensify their knowledge. This is a fast track and advanced course having rigorous case studies based methodology throughout the duration.


“The difference between a successful person and others is not a lack of strength, not a lack of knowledge but rather a lack of will”

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:


  • Comprehensive knowledge and training earned in less time
  • Recognized diploma certificates indicating candidate proficiency in the subject
  • Procedure for the documents submission e.g. DMF,/E-CTD, Dossier
  • Separate Description of Regulations for Biologics, Medical Device/Pharmaceutics
  • Loan License ( Contract Manufacturer)
  • Excellent e-tools which make the course even more interactive and easy to access.
  • Hatch Waxmann Act; Bolar Provisions
  • Practical knowledge making industry ready professionals
  • 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

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. The highly regulated healthcare industry offers tremendous job prospects. IBRI’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.

Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals. The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma and medical device products, regulatory agencies like US FDA, UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease. 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.


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 manager
  • Regulatory Affairs Head/ Director
  • Compliance specialist
  • Medical Information Associates
  • Clinical research associate
  • Drug Inspector/Drug Controlle
  • Drug Safety Specialist/ Regulatory Food Safety Scientist
  • Quality Operations/Quality Control/Quality Assurance
  • Director of 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".