Regulatory Affairs E-learning Program

Course Price: 16600
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The course is designed for students and industry professionals who have little or no knowledge in regulatory affairs. This course will help them understand the fundamental and concepts of regulation prevailing in various countries. It will enhance their knowledge and skills in the field of RA.An RA skilled professional can work in various departments as RA knowledge is diversified and useful to both international marketing professionals as well as QA /QC personnel. Apart from that they have their own department also called RA department where they focus mainly on Marketing Authorization approvals from various countries and in house documentation.

#COURSE DETAILS:

Free Regulatory Affairs Course Online

*Program Name – PG Diploma in
Regulatory Affairs (Distance Learning)

*Duration – 10 Months

*Mode – Distance / e-Learning

*Fees – Rs 16,600/-

# COURSE HIGHLIGHTS:

* Completely Online (From Admission to Examination)

*Self Paced program designed for Working professionals and students pursuing higher studies

*Includes Study materials (Hard Copy- Books) & e-Learning materials (PPT’s, MCQ’s, FAQ’s etc…)

* Online Interaction option with the Faculty

* Industry Accepted Course Curriculum

*Certificate on Course Completion

* Online Examination (MCQ Type)

* 100 % Placement Assistance & Career Guidance

# TOPICS COVERED:

-Introduction to Regulatory Affairs

-Introduction to Major Regulatory Bodies: US FDA, UK MHRA, EDQM, EMEA, DCGI, CDSCO, MHLW

-Introduction to Regulatory Guidelines: ICH & WHO & Pharmacopoeias

-CTD & ACTD Submissions (API & Formulation)

-Overview of US Submissions: US DMF (Type I to Type V), NDA, ANDA

-Overview of EU Submissions: EU DMF, ASMF, CEP/ COS

-Introduction to eCTD Submission

-Overview of Module 4 & 5: Non-Clinical and Clinical Documentation

-PSUR’s, Annual Updates & Renewals

FOR DETAILED INFORMATION:

Call us at:
9595750750 / 020 46704472

Mail us at: info@regulatoryinstitute.com