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Certification Verification

Drug Regulatory Affairs

PC103: Professional Certificate in Drug Regulatory Affairs

Duration: 6 Months

Fee: 11999/-

To learn the role and scope of regulatory authorities, their requirements, applicable ICH guidelines etc.

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Fee: 7999/-

Professional Certification in Drug Regulatory Affairs

Course Overview

About this course

Certification in Drug Regulatory Affairs-Drug Regulatory Affairs is the result of a government’s desire to protect public health by controlling the safety and efficacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

The worldwide outsourcing market for regulatory affairs is expected to grow at the CAGR of 14.6 to 2040 and the industry is expected to reach $4.5B.

The Professional Certification in Drug Regulatory Affairs (PCDRA) course allows participants to acquire in-depth knowledge of the relevant global regulatory authorities and reporting requirements, regulation of medical devices, roles and responsibilities. The PCDRA course will help you to succeed in your profession as a Drug Regulatory Associate or an Executive.


Who Should Take This Course?

  • DRA Professionals
  • Aspirants (students/ working professionals) from following health science background: Pharmacy, Medicine, Dental, Nursing, Public Health, Life-Science, Physiotherapist, Traditional/ Alternative Medicine etc.

What am I going to get from this course?

  • 5 high-quality learning modules with an online exam.
  • In-depth knowledge on Global Regulatory Authorities.
  • Learn Regulatory Requirements in Pharmaceutical.
  • Learn Medical Device Regulation with ICH Guidelines.
  • Learn roles and responsibilities of DRA Personnel.
  • Certificate and Performance Card on successful completion.
  • Opportunity to explore your career as Drug Regulatory Associate.

Curriculum

Module 1 1 – Regulatory Considerations when filling an investigation new drug application
Unit 1 Lecture regulatory Considerations When Filing An Investigation New Drug Application I-1
Unit 2 Regulatory Considerations When Filing An Investigational New Drug Application Ii-2
Unit 3 Regulatory Considerations When Filing An Investigational New Drug Application Iii-3
Unit 4 Regulatory Considerations When Filing An Investigational New Drug Application Iv-4
Unit 5 Regulatory Considerations When Filing An Investigational New Drug Application V-5
Module 2 2. Clinical Study & Start-up Activities Part
Unit 1 Clinical Study & Start-up Activities I-1
Unit 2 Clinical Study & Start-up Activities II-2
Unit 3 Clinical Study & Start-up Activities III-3
Unit 4 Clinical Study & Start-up Activities IV-4
Unit 5 Clinical Study & Start-up Activities V-5
Module 3 3. Clinical Trials Phase 1
Unit 1 Clinical Trials Phase 1 Part I-1
Unit 2 Clinical Trials Phase 1 Part II-2
Unit 3 Clinical Trials Phase 1 Part III-3
Unit 4 Clinical Trials Phase 1 Part IV-4
Unit 5 Clinical Trials Phase 1 Part V-5
Module 4 4 – Clinical Trials Phase 2
Unit 1 Clinical Trials Phase 2 Part I-1
Unit 2 Clinical Trials Phase 2 Part II-2
Unit 3 Clinical Trials Phase 2 Part III-3
Unit 4 Clinical Trials Phase 2 Part IV-4
Unit 5 Clinical Trials Phase 2 Part V-5
Module 5 5 – Industry Considerations with Phase 3 Clinical Trials Part
Unit 1 Industry Considerations with Phase III Clinical Trials I-1
Unit 2 Industry Considerations with Phase III Clinical Trials II-2
Unit 3 Industry Considerations with Phase III Clinical Trials III-3
Unit 4 Industry Considerations with Phase III Clinical Trials IV-4
Unit 5 Industry Considerations with Phase III Clinical Trials V-5
Unit 6 Industry Considerations with Phase III Clinical Trials V-5
Module 6 6 – New Drug Application, Filling, Product Labeling
Unit 1 Industry Considerations with Phase III Clinical Trials V-1
Unit 2 Industry Considerations with Phase III Clinical Trials V-1
Unit 3 New Drug Application, Filing, Product Labeling II1-3
Unit 4 New Drug Application, Filing, Product Labeling IV-4
Unit 5 New Drug Application, Filing, Product Labeling V-5
Unit 6 New Drug Application, Filing, Product Labeling VI-6
Module 7 Quiz- Online Test
Unit 1 Quiz- Online Test

FAQs

  1. What will be the mode of learning and do I need to visit anywhere to take this course?
    The mode of learning is completely online and you are not required visit anywhere to take this course. You can easily learn and complete this course from your location. You should have a device (laptop/ desktop) with internet connect.
  1. How will you deliver the course modules?
    You simply need to log in with the Username and Password at our Online Moodle Portal to start learning. The access will be granted to you via email within 24 hrs. of fee payment.
  1. 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.
  1. Is there any specific timing to take the course modules?
    We have made it very convenient for you. All the course modules are pre-loaded on the website, so you can learn the modules as per your convenient timings.
  1. How will you conduct the exams?
    Exams will be online. Once you are through with course modules and want to take examination, you just need to drop a request mail at info@pharma-research.in Request to take the online exam can be sent at any time.
  1. When will I receive the Certificate and Performance Card?
    Once you attempt and submit your online exam for evaluation, we generally take 7 business days to evaluate and issue Certificate of Completion along with Performance Card
  1. How will you send the Certificate of Completion?
    The Certificate would be issued through email upon successful completion. The issued certificate would be print-ready but if you wish to receive a hard copy of Certificate then a minimal charge towards processing, printing and courier would be applicable.
  1. How to enroll and pay the fee?
    To enroll, you simply need to view the link HOW TO ENROLL.
  1. Can I pay the fee in installments?
    Yes, you can pay the fee in maximum 3 installments. To pay the fee in installments, you need to contact us at info@pharma-research.in

You can also view our FAQs page for further queries.

Student 3200

Length: 4 weeks

Timings: Self Paced

Language: English

Effort: 55 hrs. approx

Skill Level: All

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