Enquire

Submit your enquiry for Regulatory Affairs

Please enter valid question or comment

Please enter your name.

Please enter valid Phone Number

Please enter the Pin Code.

By submitting, you agree to our Terms of use and Privacy Policy

Connect With Indian Biosciences & Research Institute

You have reached a limit!

We only allow 20 Tutor contacts under a category. Please send us an email at support@urbanpro.com for contacting more Tutors.

You Already have an UrbanPro Account

Please Login to continue

Please Enter valid Email or Phone Number

Please Enter your Password

Please Enter valid Password or OTP

Forgot Password? Resend OTP OTP Sent

Sorry, we were not able to find a user with that username and password.

We have sent you an OTP to your register email address and registered number. Please enter OTP as Password to continue

Further Information Received

Thank you for providing more information about your requirement. You will hear back soon from the trainer

Share

Regulatory Affairs

Regulatory Affairs

Online Instructor led Course

Platform:

10,500

No Reviews Yet
2 Interested

About the Course


Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including Pharmaceuticals, Veterinary Medicines, Medical Devices, Pesticides, Agrochemicals, Cosmetics and Complementary Medicines. Most companies, whether they are major multinational Pharmaceutical Corporations or Small, Innovative Biotechnology Companies, have specialist departments of Regulatory Affairs professionals. The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. With the aim of providing training IBRI has launched the course in Regulatory Affairs with the mission to train students and professionals who can help the industry to work under regulatory environment

Topics Covered

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.
Biopharmaceuticals
Market Authorization, Audits and inspections.

Who should attend

Any Science Graduate or Having similar work experience

Pre-requisites

Need to be a science graduate

What you need to bring

Registration Form
Educational Certificate Documents Photo copies
Course Fees
Photograph

Key Takeaways

Certificate and Mark-sheet if qualify the final examination
Content
Reviews
There are no Reviews yet. Be the First to Review
Questions and Comments

Thousands of experts Tutors, Trainers & other Professionals are available to answer your questions

Comment ?

Questions Guidelines

  • Start your question with simple statements like "what", "when", "where", or "how".
  • Ensure your question or answer is not offensive or insensitive - it may be voted down or banned.
  • Please provide as much detail as possible as this will allow our members to better understand and respond to your question.
  • Take some time to categorize your question. This will greatly help other users find the question.


You can add upto 6 Images

Ask


There are no Reviews yet. Be the First to Review

Date and Time

Not decided yet.

cash back100% Money Back Guarentee

About the Trainer

Dr Kumud Sarin

PhD from Delhi University


16 to 17 years academic experience
Seats Left-

Students Interested 2

Course Id: 18513