Certificate Program in Drug Regulatory Affairs (CPDRA)
This self-paced certificate course will provide you a comprehensive training on the concepts & processes in drug regulatory affairs in compliance with applicable GCP & regulatory guidelines. This course will also train you for the entry-level job positions in drug regulatory affairs (DRA Executive or DRA Associate).
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About the 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.
Certificate Program in Drug Regulatory Affairs (CPDRA) 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?
This course is specially designed for:
- Health-science candidates (Pharmacy, Life-Science, Medicine, AYUSH, Dental, Nursing, Physiotherapy, Ph.D. etc.) who are looking to gain knowledge & start their career in the drug regulatory profile.
- Fresher and experienced DRA personnel.
Rs.7600 9500 20%Off
|20% Fee Discount until 20th April|
|Batch Starts 30th April 2019|
|Learning: Distance and Online|
|Duration: 6 Months|
|Efforts: 60 Hours Approx.|
|Assessment: Single Exam|
|Includes: Certificate of Completion|
|Course Access: Lifetime|
|International candidate can email at email@example.com to pay the fee in US$.|
Module 1: Introduction to Drug Regulatory Affairs (Evolution, Scope and Role of DRA)
Module 2: Regulatory Authorities (USFDA, Canadian, EU, CDSCO, ICH, WHO)
Module 3: Regulatory Requirements in Pharmaceutical (Drug Product Lifecycle – Development, Regulatory Submission, Regulatory Compliance etc.)
Module 4: Medical Device Regulation (Definition and Classification, Steps in 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.
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 career in DRA domain
Global regulatory framework of DRA
Global medical device regulation
Applicable regulatory requirement and ICH guidelines
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 firstname.lastname@example.org
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