Advance Program in Drug Regulatory Affairs by CLINI INDIA: Fee, Duration, How to Apply

Quick Facts

particular	details
Medium of instructions English	Mode of learning Self study, Virtual Classroom	Mode of Delivery Video and Text Based

Course overview

The Advance Program in Drug Regulatory Affairs certification course duration is 4 months. The certification programme offers an overview of general regulatory requirements to get pharmaceutical products into the market. Students will gain a deep understanding of the global regulatory affairs. The course offers flexible learning opportunities to students and working professionals.

Students will learn to collaborate with industry stakeholders, leading to effective development and marketing of pharmaceutical products. The Advance Program in Drug Regulatory Affairs certification by Clini India offers a comprehensive curriculum that covers the key topics of clinical research. It is developed in consultation with industry experts including the latest trends, and up-to-date knowledge.

Also Read: Online Pharmacogenetics And Drug Development Courses & Certifications

Course and certificate fees

Fees information

₹ 18,000

The Advance Program in Drug Regulatory Affairs certification fee is Rs 18,000. Students can pay the fee online through the online payment apps using the course scanner QR code available on the official course website

Advance Program in Drug Regulatory Affairs Fee Structure

Certification Course	Fees
Advance Program in Drug Regulatory Affairs	Rs 18,000/-

certificate availability

Yes

certificate providing authority

CLINI INDIA

Who it is for

Compliance manager Drug inspector Safety manager

The programme is crafted for aspiring students, and working professionals to enhance their skills and knowledge. This course is also beneficial for:

Eligibility criteria

Academic Qualifications

The participants must have the education background of B.Pharm, M.Pharm and Pharm.D, B.Sc. M.Sc and Ph.D (Biotechnology, Microbiology, Biochemistry and Nursing), B.E, B.Tech. M.Tech (Biotech/Biomedical Engineering), and B.P.T, M.P.T, B.D.S, B.A.M.S, B.H.M.S and M.B.B.S.

Certification Qualifying Details

Advanced Program in Drug Regulatory Affairs (APDRA) is a blockchain-based regulatory affairs certification. Students will receive a completion of the course certificate after pursuing the course from Clini India.

What you will learn

After completing the Advance Program in Drug Regulatory Affairs certification syllabus, the students will gain knowledge of regulatory affairs in the pharmaceutical industry, global regulatory authorities and their roles. They will also learn about the drug development process, regulatory submissions and strategies, and pharmaceutical quality assurance and GMP compliance with the help of industry experts.

Students will gain a comprehensive understanding of Regulatory Strategies for Different Types of Products, Regulatory Compliance and Post-Market Surveillance, Regulatory Affairs in Specific Regions and Emerging Trends and Future Developments in Regulatory Affairs. Upon completing the Advance Program in Drug Regulatory Affairs training, participants will gain a deep understanding of regulatory affairs ethics and compliance.

The syllabus

Introduction to Regulatory Affairs

Overview of Regulatory Affairs in the Pharmaceutical Industry
Global Regulatory Authorities and their Roles
Regulatory Frameworks and Guidelines

Drug Development Process

Preclinical Development
Investigational New Drug (IND) Application
Clinical Trial Phases and Requirements
New Drug Application (NDA) and Marketing Authorization Application (MAA)
Post-Approval Activities

Regulatory Submissions and Strategies

Preparation and Compilation of Regulatory Submissions
Common Technical Document (CTD) Format
eCTD (Electronic Common Technical Document)
Accelerated and Orphan Drug Designations
Expedited Pathways and Breakthrough Therapy Designation

Pharmaceutical Quality Assurance and GMP Compliance

Good Manufacturing Practices (GMP) Guidelines and Regulations
Quality Assurance and Quality Control in Pharmaceutical Manufacturing
Good Laboratory Practices (GLP)
Auditing and Inspections
Quality Risk Management

Regulatory Strategies for Different Types of Products

Generics and Biosimilars
Over-the-Counter (OTC) Drugs
Medical Devices and In-Vitro Diagnostics
Combination Products
Advanced Therapies (Gene and Cell Therapies)

Regulatory Compliance and Post-Market Surveillance

Pharmacovigilance and Adverse Event Reporting
Post-Market Surveillance and Safety Updates
Labeling and Packaging Requirements
Post-Approval Changes and Variations
Lifecycle Management of Pharmaceutical Products

Regulatory Affairs in Specific Regions

FDA Regulations and Procedures (USA)
European Medicines Agency (EMA) and European Union (EU) Regulations
Health Canada and Health Product Regulatory Authority (HPRA) Regulations (Canada)
Pharmaceuticals and Medical Devices Agency (PMDA) Regulations (Japan)
Other Key Regulatory Authorities (Asia, Latin America, etc.)

Emerging Trends and Future Developments in Regulatory Affairs

Digital Health Technologies and Regulatory Considerations
Real-World Evidence and Regulatory Decision-Making
Regulatory Science and Innovation
Regulatory Challenges in Global Harmonization
Ethics and Compliance in Regulatory Affairs

Admission details

Students can join the Advance Program in Drug Regulatory Affairs classes by following the below-mentioned steps:

Step 1: Browse the link mentioned below:

https://www.cliniindia.com/clinical-research-courses/advanced-program-in-regulatory-affairs/

Step 2: Candidates can click on the "Apply Online" button, and then click on the “Click Here to Fill the Form.”

Step 3: After that, they can fill up the Google application form with the required details and submit it.

Step 4: Candidates will get connected to the programme advisor.

Step 5: Select the course, submit the application form and pay the registration fee.

Step 6: The application will be reviewed, and acknowledged and students will get a confirmation call.

Filling the form

Participants should go to the course page, click on the "Apply Online" button, then click on the “Click Here to Fill the Form.” They can find a Google form, fill up the application form with the required information and submit it.

How it helps

The Advance Program in Drug Regulatory Affairs certification benefits include:

The course offers support to the students with CTD guidance for industry CDSCO, eCTD submissions, various schedules, drug development process and Indian regulations- Indian Scenario - D.
Students can access several resources, including online tests, quizzes, collaborative forums, pre-recorded video lecture materials, and 24/7 LMS access.
The course offers placement facilities that include networking, skill development, interview preparation, resume optimisation, and self-marketing.

FAQs

How long does the Advance Program in Drug Regulatory Affairs training last?

The duration of the certification programme is 4 months. The course offers in-depth knowledge of drug regulatory affairs and all its key aspects.

What are the career opportunities after pursuing Advance Program in Drug Regulatory Affairs certification course?

The career options are Regulatory Affairs Specialist/Associate, Regulatory Affairs Manager, Clinical Regulatory Affairs Manager, Quality Assurance Specialist (Regulatory Compliance), Regulatory Affairs Consultant, Regulatory Affairs Project Manager and Regulatory Affairs Specialist.

Do students get online access to LMS for the Advance Program in Drug Regulatory Affairs online course?

Students receive 24/7 access to study materials that include pre-recorded video lecture materials, quizzes, and collaborative forums.

How to apply for the Advance Program in Drug Regulatory Affairs certification course?

To enrol, candidates can visit the course's official website. After selecting "Apply Online," click on "Click Here to Fill the Form," enter relevant information, and submit the form.

What are the top sectors in the Clinical Research industry that students can join after completing the Advance Program in Drug Regulatory Affairs online course?

The top sectors are Trade Associations, international organisations, legal and compliance teams, suppliers and service providers, insurance companies, pharmaceutical companies contract manufacturing organisations, regulatory agencies, clinical research organisations, ethics committees and institutional review boards.