Regulatory Affairs Course Training Center

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Regulatory Affairs training in Hyderabad provided by GenSol Healthcare. A career in Regulatory Affairs is both a challenging and highly rewarding career. 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 GenSol Healthcare 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 Trainees are well awareness 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.

Regulatory Affairs Course Training Content & Syllabus & Modules

  • Loading... Introduction to Regulatory Affairs
  • Loading... Global Regulatory Environment
  • Loading... Pharma Regulations Practices & Procedures
  • Loading... Import and Export of Drugs in Global Pharmaceutical Industry
  • Loading... Common Technical Document
  • Loading... Good Manufacturing Practice
  • Loading... Quality Assurance and Regulation
  • Loading... Regulatory Aspects in Pharmacovigilance
  • Loading... Regulations Governing Clinical Trials & New Drugs
  • Loading... Global Drug Policy
  • Loading... Essential Documentation in Clinical Research & Regulatory Submissions
  • Loading... Clinical Trials Project Planning & Management
  • Loading... Study Start Up Process
  • Loading... Clinical Monitoring Essentials
  • Loading... Compliance, Auditing & Quality Control in Clinical Research Program

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