Regulatory affairs (RA) professionals play a very significant role throughout the drug development lifecycle, from hypothesis through drug obliteration. They provide planned, premeditated and operational direction and support for working within regulations to speed up the development and release of safe and effective drugs or devices to people around the globe. Continuous advancement in science and changes in the regulatory guidelines, healthcare division and general economics shadows the dynamic and intensifying scope of the RA professionals. RA professionals must persistently nurture and update their knowledge, ability and talent to be efficient and to press forward in their career.
Carefully planned Regulatory Affairs training and internship offered in Clinnovo Research Labs ensures strategic and technical development of the students and brings out dynamism in the students to undertake operational activities with the required efficiency and it applies to freshers, professionals in industry, research and clinical settings, and is not product-specific. We also ensures that the students are well aware of the regulatory requirements and guidelines, timelines and that they are well updated about the ever-changing legislation in all the regions where the bio pharmaceutical company (MAH- marketing authorization holder) intends to market its products.
The training programs provided by Clinnovo are suitable for Life science Graduates, Doctors, Medical Professionals, Pharmacists etc.
Anyone of the following minimum qualification is mandatory to eligible.
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B.Sc / M.Sc in Biotechnology
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B.Sc / M.Sc in Microbiology
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B.Sc / M.Sc in Genetics
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B.Sc / M.Sc in Biochemistry
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B.Sc / M.Sc in Life Sciences
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M.B.B.S / B.D.S / B.A.M.S / B.H.M.S
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B.Pharmacy / M.Pharmacy
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Pharm.D
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Graduates or Post Graduates in Nursing
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B.E (BT) / B.Tech (BT)
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Ph.D in Life Sciences / Biomedical Science
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About Regulatory Affairs
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Drug Discovery
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Innovative and generic drugs
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Ethics in Clinical Research
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Clinical Trial Information Validation and Auditing
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A Regulatory Overview of Medical Device Development
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International Food, Drug, Medical Device Regulation and its Legal Issues
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Drug approval procedures in India, USA, and Europe
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International Clinical Trials
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ICH guidelines and ICH-GCP
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CTD – eCTD
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Responses to authority queries
During the training period thefollowing modules will be covered as a part of Student career Improvement Program.
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Communication and Soft skill development
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Just A Minute Sessions
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Seminars
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Case studies
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Mock interviews
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Guest lectures
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Student improvement program
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Professional career building
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Organizing Resume
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Knowledge Sharing on new techniques
For more information please contact at
9912868928
Reviews
Rajender bukka
Executive - Regulatory Affairs
I have joined clinnovo in hyderabad and learned classroom Regulatory affairs training along with Job Assistance. The training at Clinnovo was excellent and the information provided was very updated. The daily tasks and assessment helped me to learn the subject more easily. The material provided by Clinnovo was very informative.