Professional Certificate in Drug Regulatory Affairs (DRA)
Become a master of regulatory affairs with online Regulatory Affairs Certificate. This Regulatory Affairs course will provide you training and skills on Scope and Role of Regulatory Authorities, Regulatory Requirements in Pharmaceuticals and Medical Devices, Application of ICH-GCP Guidelines etc. This course will also help you to prepare for the entry-level job positions in Regulatory Affairs domain.
4.6 Average Rating (2300+ Course Participants)
$120 $150
20% Fee Discount until December 20
December 2024 Batch
Last Date of Application: December 31, 2024
Online & Self-Paced
40-50 Hrs. of Efforts Required
Course Overview
Drug Regulatory Affairs domain is a result of the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines.
Professional Certificate in Drug Regulatory Affairs Training Program enables learners to take in-depth knowledge of Global Regulatory Authorities and Reporting Requirement, Pharmaceutical Regulatory Requirements, Medical Device Regulations, Application of ICH-GCP Guidelines etc. Check the complete Course Curriculum.
This online Regulatory Affairs Certificate (RAC) course PCDRA would enable you to excel your career as Drug Regulatory Associate in Pharmaceutical and Medical Device organizations.
Course Features
Course Fee: $120 (20% Discount)
Batch: December 2024
Last Date: December 31, 2024
Course Duration: 12 weeks
Certificate Validity: Global
Timings: Self-Paced
Mode of Learning: Online
Exam: Single, Online
Efforts: Approx 40 to 50 Hours
Content Access: Lifetime
Language: English
Includes: Exam Fee and Certificate of Completion
Course Curriculum
Regulatory Affairs course syllabus covers the following modules:
Module 1: Introduction to Drug Regulatory Affairs ( Basics of Regulatory Affairs, Evolution of Regulatory Affairs, Scope of Professional Responsibility, Role of Regulatory Affairs in Product Development, Potential Regulatory Positions, Career Growth Opportunities)
Module 2: Regulatory Authorities (US-FDA Organization and its Regulatory Mechanism and Document, Canadian Regulatory System, EU Regulatory Framework, CDSCO India, ICH, WHO)
Module 3: Regulatory Requirements in Pharmaceutical ( Drug Product Lifecycle, Clinical Development, CTD and eCTD, NDA, Regulatory Compliance Activities, GLP, GCP, GMP, Pharmacovigilance)
Module 4: Medical Device Regulation (Definition and Classification of Medical Devices, Steps in Medical Device Development, Product Lifecycle)
Module 5: Overview of ICH Guidelines (Stability Testing of New Drug Substances and Products, Stability Testing : Photostability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Stability Data Package for Registration Applications in Climatic Zones III and IV, Analytical Validation, Impurities Guidelines, Specifications Guidelines, Good Manufacturing practice Guidelines)
Assessment through Self-paced Online Exam
Learner’s Profile
The online RA Certificate course caters to global health science working professionals, masters, and graduates from international medical and healthcare universities, CROs and pharmaceutical companies. Participants from 35+ countries are part of this program.
Schools, Universities and Companies
Region-wise Distribution of Course Participants
Happy Learners
Gloria Rossoni
Clinical Trial assistant, Italy
A very good course on Regulatory Affairs.
Team Lead, US
Excellent course with easy methodology.
Kim Li Yang
Researcher, Hong Kong
DRA course helped me understanding the basics of Regulatory Affairs and applying into my role.
Research Project Manager, India
Indeed one of the best course in Drug Regulatory Affairs. I am very hopeful that it would be very helpful to accelerate my career growth.
Lab Assistant, US
Elaborated and well conceptualized course.
Doctor, US
The course modules were comprehensive.
Course Eligibility
- Health care professionals
- Aspirants (graduates, masters, PhD and working professionals) from health science background: Pharmacy, Medicine, Dental, Nursing, Public Health, Life-Science, Biotechnology, Physiotherapist, Traditional/ Alternative Medicine etc.
Enrollment Process
The enrollment process consists of 3 simple steps to enroll in the course.
STEP 1: ADD TO CART
Click Enroll Now Button, Click Add to Cart Button, and Click Proceed to the checkout button.
STEP 2: FILL THE DETAILS
Fill your personal and billing details on the checkout page, Check T&C Box and Click Pay Now Button
STEP 3: PAY THE FEE
Pay the course fee securely via PayPal with your Card or Net Banking & get immediate access to the course.
To know step by step process visit the Page HOW TO ENROLL
Course Benefits
- 5 online self-paced learning modules (approx. 40 hrs. of learning).
- A self-paced online exam for your assessment.
- Certificate of Completion and a Performance Sheet on successfully completing the course.
- Opportunity to explore a career in Regulatory Affairs.
Interested to enroll in 2 or more courses?
Save more with our Course Plans made for individuals and teams.
Top FAQs
When will I get access to the course after paying the fee?
It generally takes up to 48 hours to email you the course login credentials.
Can I complete the course earlier than 12 weeks?
Yes, you can.
How will the course modules be delivered to me?
We will email you the log in information. You can access our learning portal with the provided details.
I am a busy working professional; can I take this course?
Yes, more than 80% of course participants are working. The course modules are completely self-paced. So, you can finish the course at your own pace and time.
I am a student at present; can I take this course along with my studies?
Yes, you can take this course along with your regular studies.
Is there any specific time to take the course modules?
No, the modules are self-paced. You can learn the module as per your convenience.
How do you conduct the exam?
Once you are through with the course modules and want to take the examination, you just need to drop us an email to get access to the exam.
A request to take the online exam can be forwarded at any point in time.
When will I receive the certificate and performance sheet?
We generally take up to 14 working days to evaluate you and issue a Certificate of Completion with Performance Sheet after submission of your exam.
How will you send me the certificate of completion?
A print-ready Certificate of Completion will be issued through email upon successful completion.
Can I pay the fee in installments?
Yes, you can pay the fee in a maximum of two installments. To pay the fee in installments, you need to contact us at admin@dnasysacademy.com
You can also check our FAQ page for further queries.
More Courses
Certificate Program in Clinical Research (CPCR)
Professional Certificate in Pharmacovigilance (PCPhV)
Professional Certificate in Clinical Data Management (CDM)
