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Certification in Advanced Regulatory Affairs

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Regulatory Affairs course Training Excellence

“With the most up-to-date regulatory affairs Guidelines and innovative approaches to learning, we prepare our students for a successful career in regulatory affairs.”
In the Certification in Advanced Regulatory Affairs course, the candidate will comprehensively understand legal, scientific, and business concerns to perform their work effectively. You will know that products are developed and marketed within the legal framework and as per recommended guidelines.
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Join Advanced Regulatory Affairs course at BCRI, with Excellent Placement Support.

What we Teach in Advanced Regulatory Affairs course?

In Advanced Regulatory Affairs course, the candidate will comprehensively understand legal, scientific, and business concerns to perform their work effectively. You will know that products are developed and marketed within the legal framework and as per recommended guidelines.

About Regulatory Affairs

Regulatory Affairs is one of the crucial aspects of Pharmacovigilance which is an essential part of the more significant healthcare industry. This role demands expertise in regulation to be able to become successful. Regulatory domain specialists are expected to be interested in the regulation behind the safety and efficiency of drugs in the healthcare industry.Regulatory specialists play a significant role in communication between their company and regulatory bodies such as the FDA, EMA, etc. An example of the projects you might be involved in during your professional career is studying global regulations, gathering data about various products relevant to the industry, preparing product labels, coming up with arguments for new drug/medical device licenses, submitting product information to agencies, retrieving regulatory cases, and screening regulatory websites. Companies look for freshers who have gone through relevant training in regulatory affairs and have a good understanding of regulatory guidelines provided by various regulatory authorities.

What you learn from Regulatory Affairs Course

This course provides an understanding of legal, scientific, and business concerns that are essential for the successful practice of regulatory affairs. It also covers the legal framework and recommended guidelines. Advanced Regulatory Course will help you prepare product labels and arguments for new drugs/medical device licenses, submit product information to agencies, retrieve regulatory cases, and screen regulatory sites. The regulatory Affair course will give you a good understanding of regulatory guidelines various regulatory authorities provide.
  • Understanding of legal, scientific, and business concerns
  • Good understanding of regulatory guidelines provided by various regulatory authorities.
  • Regulatory specialists play a significant role in communication between their company and regulatory bodies such as the FDA, and EM.
Join a Job oriented Training at BCRI, with Excellent Placement Track Record.
Learning Objective
  • Overview of Pharmacovigilance – Importance of safety monitoring
  • Overview of all Pharmacovigilance Regulations
  • Regulatory guidelines and laws governing Pharmacovigilance across Globe
 ICH Efficacy Guidelines for medicine safetyCIOMS Working Group and Contributions in Pharmacovigilance
  • E2A
  • E2B
  • E2C
  • E2D
  • E2E
  • E2F
  • CIOMS 1
  • CIOMS 2
  • CIOMS 3
  • CIOMS 4
  • CIOMS 5
  • CIOMS 6
  • CIOMS 7
  • CIOMS 8
  • CIOMS 9
  • Regulatory Requirements in the USA – FDA Perspective.

What, When, How to Report, Submission Methods

  • Regulatory Requirements in Europe – EMA Perspective and Regulation.

What, When, How to Report, Submission Methods

  • The regulatory system in India (National Pharmacovigilance Program and centers)

What, When, How to Report, Submission Methods

  • Industry method of Regulatory site screening and searches
  • Identification of safety reports
  • Identification of safety updates and changes
  • Identification of labelling changes
  • Extended EudraVigilance medicinal product dictionary
  • Company Core Data Sheet Preparation
Upcoming Batches

FAQs About Regulatory Affairs

Candidates who are interested in the Regulatory domain of Pharmacovigilance, including freshers and experienced candidates.

Regulatory Affairs Course is an advanced course for any life science graduate who wants to enter the regulatory domain, including both freshers and experienced candidates.

The course duration is one month In- class.

20 Session of 1 hour Each

The course requires candidates to be familiar with clinical trial fundamentals. There will be a brief discussion in class about Pharmacovigilance. 

Recommend Course: Certification in Pharmacovigilance & Basics of Regulatory Affairs. 

Reviews From Our Happy Students

Creating Vibrant Career & Secured Future!
Abhishek Nemmaniwar
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It was a wonderful experience learning PV and Regulatory affairs with Mayuri mam and BCRI. The way mam taught was amazing, clearing each and every doubt be it of the simplest level. Learning was just fun.
Aman
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CDM training i joined in BCRI, due to my back ground, they suggested Regulatory affairs also, in december i completed my course, Thanks to Dev Sir, i got a basic job last month in Cipla. Thanks BCRI
Talat Fatima
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It was one of my best decision to join BCRI for Pharmacovigilance and Regulatory Affairs Course. The course is well structured and well planned to provide maximum information in very short span of time. But, I believe that the course Lifeline is "Mr. DEV PRAKASH YADAV." Read More
Krishna Dave
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It was great experience with BCRI. I joined and completed Pharmacovigilance and Regulatory affairs course. I must say that they have structured and well organised curriculum. I specially thankful to Mr. Devprakash (course tutor)as he has great knowledge and understanding of this topic and also have good teaching skills
BraQweku
BraQweku
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As Bpharma student, I was in confusion to take a course, i enquired many organizations, finally, i reached BCRI, i took ADCR, which have CDM, PV, and regulatory affairs, it was 4 months, i have learned many aspect of clinical research, the trainers were experienced, and the admin helped me a lot when i get any simple issue too. Finally, i thank BCRI for the fabulous sessions.
Nikitha
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I completed my Pharmacovigilance and advanced regulatory affairs, It was a nice experience and I got to learn many new things in clinical research. The trainer have strong knowledge. They cleared all the doubts whenever we asked him. Finally i got placed in IQVIA as safety associate, i strongly recommend BCRI for clinical research courses
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