I am glad to have trained from Covalent in Drug Regulatory Affairs course. The training went quiet well with real time examples and test cases. I would strongly recommend this institute.
Topic 1: Introduction to RA:
What is Regulatory Affairs, Importance of RA department, Roles and their functions, and Worldwide regulatory agencies
General overview of the Pharmaceutical Industry, role of various departments and their functioning.
Topic 2: Drug approval procedure in US:
US(FDA) Introduction, 21CFR, INDA, NDA, ANDA drug applications, Patents and their types, GDUFA, Post approval changes (Annual reports, CB-30 and prior approval supplements) and Types of DMF’s.
Topic 3: Drug approval procedure in Europe:
Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions) and approval procedures for drug substance (DMF and CEP).
Covalent Provides Realtime projects working on Documentation process, Dossier preparation, CTD, e-CTD, ICH, GCP, MHRA Guidelance.
Working on National and International Regulations.
Yes
If you miss a class we can provide recording video for particular session or we can arrange you the back up session.
Yes
Yes
Doubts clarification up to getting a job
Resume preparation
Malk interviews
Placement Assistance
Class Room & Online Live sessions
Real-time projects
Working faculties
Placement assistance
Resume preparation
Doubts Clarifications
Covalent provides training certificate after completion of the course.
I am glad to have trained from Covalent in Drug Regulatory Affairs course. The training went quiet well with real time examples and test cases. I would strongly recommend this institute.
Hi this is Sunitha, from Hyderabad. I am thankful to covalent for showing placements in Hetero Pharma. a best training place for International Drug Regulatory Affairs Training.
I have joined Covalent in hyderabad and learned classroom Regulatory affairs training along with Job Assistance. The training at Clovalent was excellent and the information provided was very updated.
It was a great experience. It is a very good platform for all those who is working in Pharma industry being a quality, development or Regulatory personal, fresher's or experienced one.
Covalent helps you understand Regulatory affairs in a very simplistic but practical way. You can easily apply the knowledge to your day to day documentation activities. Would recommend this course to my friends and colleagues.
Teaching staff is experienced and from top most pharma industry. All doubts and queries are clarified during session. Faculty is also very good and cooperative. Notes provided are easy to understand. More focus on current updates in pharma industry explained with examples and also with sharing their experiences.
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