Centre for Drug Regulatory Affairs has launched a 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲 𝗖𝗼𝘂𝗿𝘀𝗲 𝗼𝗻 𝗚𝗲𝗻𝗲𝗿𝗶𝗰 𝗗𝗿𝘂𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀. The course aims at providing a know-how of regulatory submission requirements for a generic drug to USFDA.

Objectives of the course: 

1. Understanding the stages of regulatory control.

2. Regulatory forms and procedures of USFDA.

3. Hands-on training in Pharma Ready® an eCTD software.

4. Detailed content and requirements of USFDA form.

Duration: 15 hours

Timings: 09.30 am – 04.00 pm IST

Last Date for registration: August 1, 2021

Coordinator: Dr Krishnamurthy Bhat, Professor, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal.

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