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Pharmaceutical Regulatory Affairs Course

Pharmaceutical Regulatory Affairs Course
flexible workload of 4 to 360h
certificate recognized by MEC

What will I learn?

Become proficient in the fundamentals of pharmaceutical regulatory affairs with our comprehensive course tailored for pharmacy professionals in India. Delve into crucial regulatory frameworks, including ICH, EMA, and FDA guidelines, adapted to the Indian context. Acquire expertise in regulatory documentation, covering areas from clinical trial data to labelling and manufacturing requirements as per Indian regulations. Learn the complexities of the submission process, encompassing document preparation and electronic systems used in India. Develop strategic compliance skills focusing on quality control, risk management, and effective communication with Indian regulatory authorities. Enrol now to advance your career in the Indian pharmaceutical sector.

Elevify advantages

Develop skills

  • Master regulatory frameworks: Navigate ICH, EMA, and FDA guidelines with confidence, with a focus on their application within the Indian regulatory landscape.
  • Develop submission plans: Create effective timelines and identify key milestones, relevant to Indian regulatory submissions.
  • Prepare regulatory documents: Ensure compliance in clinical trials and labelling, adhering to Indian regulatory requirements.
  • Utilize electronic systems: Streamline submissions with advanced digital tools used by Indian regulatory agencies.
  • Implement compliance strategies: Enhance quality control and risk management, in accordance with Indian regulatory standards.

Suggested summary

Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.
Workload: between 4 and 360 hours

What our students say

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The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Very great course. Lots of rich information.
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