Bioinformatics institute

IBRI Speak to an expert: +91 9999509892
IBRI email: info@ibri.org.in

Indian Biosciences and Research Institute

REGULATORY COMPLIANCES AND AFFAIRS

Course Rationale

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 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 is 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.

Process of Dossier

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

IBRI inspired by Hannibal phrase ‘Find a way or make one’ initiated to train pharma aspirants to achieve their career goal in the challenging field of regulatory affairs conducts the courses/training in Regulatory affairs with the following objectives:

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.

Benefits and Outcomes

The regulatory affairs market has always been of a fluid nature due to the constant changes in regulations in the world and Regulatory adherence is imperative for obtaining and maintaining marketing authorization. The knowledge gained from these courses regulatory affairs is essential for continued success of pharmaceutical and related industries within the world to get approval and authorization. The courses will empower the students with the tools required to successfully navigate the minefield i.e.GCC, FDA, TGA, EU and other regulatory affairs compliance systems. The course will ensure that delegates are completely up to date with the latest in legislation. These courses equip the participants with the knowledge and confidence to instigate the optimization of the in-house regulatory procedures.

Learning Outcome:

  • 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,/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.

Special Features of this Program: - It includes the maximum syllabus of RAC Certification for Regulatory Affairs Professionals.

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. 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 & 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.

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
  • Regulatory Affairs Consultants

“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.”

Certificate Program in Regulatory Compliances and Affair [3 Months]

  • Paper-I: Introduction to Regulatory Affairs
  • Paper-I:International Licensing and Drug Regulatory Affairs

Certificate Program in Regulations for Biologics and Pharmaceutical Product [6 Months]

  • Paper-I: Introduction to Regulatory Affairs
  • Paper-I:International Licensing and Drug Regulatory Affairs
  • Paper-III:Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
  • Paper-IV:Global Regulatory Compliance Systems

Certificate Program in Food Regulatory Affairs [6 Months]

  • Paper-I: Introduction to the European Union and Food Regulatory Affairs
  • Paper-I:International Food Regulatory Affairs and Current issues
  • Paper-III:Food Regulatory Affairs in India (FSSAI, Approvals etc.)
  • Paper-IV:Risk Analysis, HACCP, and Health

Comprehensive Program in Regulatory Affairs for Pharmaceutics [12 Months]

  • Paper-I: Introduction to Regulatory Affairs
  • Paper-I:International Licensing and Drug Regulatory Affairs
  • Paper-III:Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
  • Paper-IV:Global Regulatory Compliance Systems
  • Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH Guidelines
  • Paper-VI: Regulatory Strategy and Quality Assurance Systems
  • Paper-VII: Future of Biopharmaceuticals
  • Paper-VIII:Research Study

Courses Participation Fees

Duration Course Fees For Overseas Participants
12 Months Rs. 14500 $750
6 Months Rs.9500 $450
3 Months Rs.5000 $350

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

Fees can also be transferred by NEFT or can be paid by cash.

Dispatch Address

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

Eligibility

Any science graduate or having experience in similar industry.

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".

 

For Further Details Contact:

PROGRAM CO-ORDINATOR
Indian Biological Sciences and Research Institute
C-50, First Floor, Sec-2, NOIDA-201301(U.P)
Mob:+91-9999 509892
Tel: +91(120)412 2315
Email: info@ibri.org.in

    SEND QUERY
Name
Email
Mobile
Query

Registration Form
White decorative replica watches uk pattern dial and PVD swiss replica watches plated rose gold stainless steel gold replica watches case showing extraordinary rolex replica luxury texture.