Certificate Program in Drug Regulatory Affairs (DRA)
This online & self-paced drug regulatory certificate course will provide you comprehensive training on the concepts & processes in pharma and device regulatory affairs in compliance with applicable global regulatory and GCP guidelines. This course will also train you for entry-level job positions in drug regulatory affairs (DRA Executive or DRA Associate).
4.7 (850+ Ratings)
About This Course
Regulatory Affairs is a comparatively young, multidimensional and growing profession in the Pharmaceutical field with a desire to protect public health. DRA assures safety and efficacy of pharmaceuticals products, veterinary medicines, medical devices, pesticides, agrochemicals, orphan drugs, cosmetics and complementary medicines.
As outsourcing of jobs to India is high, the regulatory affairs industry in India is poised for rapid growth which is associated with flamboyant salaries. There are 120+ pharma companies having structured regulatory affairs department in India. Due to the entry of MNCs in India, it is expected a requirement of 30,000 competent and trained workforce in next 5 years.
If you are looking to start your career in Drug Regulatory Affairs or Pharma Regulatory Affairs or you are already in this industry without any formal training, the course “Certificate Program in Drug Regulatory Affairs” will certify and train you for the entry-level job positions like DRA Executive, Regulatory Affairs Associate.
The course will provide you a comprehensive training on scientific, practical, ethical and technical concepts of the drug regulatory affairs in compliance with regulatory guidelines. This 6 months course covers all the essential topics of DRA in 5 major modules covering 300+ topics. Each module is well explained in detail with the help of illustrations, examples, and flowcharts.
Who Should Enroll?
The course can be attended by:
Health-science professional (working/fresher/ student) from Pharmacy, Life-Science/ Biotech, Medicine, AYUSH (Alternate Medicine), Dental, Nursing, Physiotherapy, Ph.D. background who are looking to gain knowledge & start their career in the pharma or device regulatory domain.
Fresher and experienced regulatory affairs personnel.
Rs.7600 9500 20% Off
Course Highlights
20% Discount Until 15th November
Last Day to Enroll: 30th November'24
Online and Distance
Rs. 7600 / $120 After Discount
6 Months Duration
Single Online Exam
Global Acceptance
Approx. 50 Hours of Effort
Benefits After Enrollment
JOB ORIENTED CURRICULUM
Our course modules covers all the elements required to impart skills & knowledge to get a relevant job in the industry.
GLOBALLY VALID CERTIFICATE
Our course modules are based on ICH-GCP and applicable regulatory guidelines which are valid globally. So, The certificate is acceptable across the industry.
PLACEMENT ASSISTANCE
Upon course completion we help you with placements through our referrals and industry experts for the relevant job positions.
RESUME & INTERVIEW
Along with placements, we also assist you to prepare your resume as per the industry standards along with interview preparation.
Enroll & Get A Free Beautifully Designed Resume
You Have Less Than 6 Seconds to Impress the Employer.
When you enroll in a course, we transform your dull-looking CV into a “beautiful & professional CV” to make it stand out from the rest for free of cost.
We help our course participants to redesign their CV/ resume as per industry standards. This amplifies their chance to get selected for the relevant job positions.
Course Curriculum
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: Applicable ICH Guidelines in DRA (Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2, Q3, Q6, Q7)
Assessment and Evaluation through Exam
How This Works?
Upon enrollment, the course participant will get the course login details or course material before the start of batch via email.
Upon receipt of login details or material, the participant can read or log in to take the course modules anytime and from any device.
After reading all the course modules, the course participant is required to attempt and submit an exam.
Upon evaluation of exam, the certificate of completion will be issued to all the successful participants of the batch.
Learning Objectives
At the end of this course, you should be able to learn about the:
Concepts and processes involved in drug regulatory affairs
Knowledge and skills required to start a career in the DRA domain
Global regulatory framework of DRA
Global medical device regulation
Applicable regulatory requirement and ICH guidelines
Testimonials
Average Rating
Top FAQs
Is it the entire course fee?
Yes, the fee mentioned above is the entire course fee and there is no additional fee attached to this course. The fee covers the cost of course modules, exam, and certification of completion.
Do I have to take the course on specific timings?
There is no need to take the course module on particular timings. The course is self-paced and you can take the modules anytime.
Can I complete the course early also?
Yes, you can. In order to do so, you have to attempt and submit the online exam for evaluation.
I am a very busy with my professional work/ studies. What if I don’t complete the course on time?
In this case, you can extend the timelines to complete the course. You can do so by dropping a request email in advance with your registered email id at info@physislearningacademy.com
What is the difference between Online and Distance learning?
In online mode of learning, you will get login access to read the course modules. You can learn anytime and from any device. In distance mode of learning, you will receive a printed/ hard copy of course material at your corresponding address via post. So, you can choose any mode of learning as per your convenience.
How can I enroll and pay the fee?
To enroll and pay the course fee, follow the link STEPS TO ENROLL
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