Drug and Medical Device Regulatory Affairs

1 Year.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or Phd holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. 3rd and final year student also can pursue this program.

This online course covers comprehensively total drug regulatory affairs syllabus and medical devices regulatory affairs in a single course. 

In the area of regulatory affairs, course covers general Drug Regulatory Affairs with practical real life simulation. Therefore, one can get the entire knowledge of Regulatory Affairs. 

Drug Regulatory Affairs Topics 

• Fundamental to Drug Discovery Development to Commercialization
• Clinical Research – Advance Learning
• IPR strategic planning – Patent, Trademarking. Patent and trademark filing, registration, objection, opposition handling process. Patent Term Extension, Patent Term Restoration.
• Marketing Authorization Process and strategic pathways for pharmaceuticals, Biopharmaceutical products. 
• Generic Drug and Innovator Molecule’s Marketing Authorization Process
• ANDA preparation and filing  – ANDA submission, Para IV filing, first to file. 
• Portfolio Management – case based learning – Training on Loss of Exclusivity Management, Evergreening tools and techniques. Various strategic planning. 
• GMP – GMP training, GMP Audits, 483 observations, warning letter, data integrity, SOP Management, CAPA
• Stability study – Requirements, types of stability study, management of stability studies and requirements.
• Variation Management – Authorization management, regional differences. 
• DMF preparation and filing, SMF preparation and filing
• Drug Dossier Preparation, filing and management of the dossier for different product classes. 
• Advance training on biopharmaceutical – innovator and biosimilar regulatory pathway. 

Medical Devices Regulatory Affairs Topics

This course is divided into following modules

• Overview of medical devices – Introduction, Classifications and Designs.
• Understanding of the different classes of medical devices in detail.
• Practical knowledge of medical devices approval process (Pre market requirement)
• Detailed understanding of the Quality Documentation
• Handling of the Product Complaint & Product Recall.
• Handling of Product Withdrawal from market.
• Marketing, Advertising, Promotion of the medical devices
• Strategic Business Model for the medical devices companies.

US Medical Device Regulation 

USFDA regulation – 510(k) pre-market notification | Pre-market approval | Details understanding of Pre Market Approval Process with flow chart | 510k VS. PMA | Investigational Device Exemption | De Novo Petition – Medical Devices Regulation | Investigational Device Exemption (IDE) | Device Clinical Research | Early/Expanded Access of Medical Devices | Trials of Medical Devices | Humanitarian Device Exemption (HDE) | Labeling Requirement for Medical Devices | Marketing, Advertising and Promotion of Medical Devices | Unapproved use of Medical Devices

EU Medical Devices Regulation 

Medical Devices: EU Directives, Classification and Guidance, CE Marking.

Quality Management System (QMS) for medical devices company

• ISO Certification for Medical Devices company
• CE Marking for Medical Devices company
• Medical Device regulatory professionals responsibility

c-GMP Requirement for Medical Devices

Medical Devices Regulation in India

Classification from different regulatory bodies across regions

Packaging standard for Medical Devices

Medical device safety and risk management

Effectiveness/performance of medical devices

Medical Devices Life Cycle Management

Standard of Medical Devices

Case Study on Medical Devices

Here the key features of the course.

• Access the courses 24×7 at your convenience
• Online interactive sessions with the expert Industry faculty
• e-Library and e-pharma dictionary
• Access to 1000’s of real life case studies
• Online assignments & self Assessment Test
• Printed Course Material
• 24/7 Online Support With the Live Chat Facility
• Special On demand Modules
• Secure access to e-module with passwords.
• Flexible online final examination (Computer Based Test by secure mode)
• Our courses can be accessed anytime from anywhere

Benefits of the course

• Certification – Receive a personal certificate to show your subject knowledge on course completion. Most importantly, Course completion and gradation certificate is provided on the completion of the course.
• Affordable – Here in this course, you will be learning drug and medical devices regulatory affairs both under single course. Hence, you will get excellent value through our cost-effective prices than purchasing both the course separately.
• Flexibility – This is self paced learning. Hence, you can attend the course at own convenience. This lets you complete the interactive course at your own comfort. Therefore, it saves saves you time through the convenience of online availability.
• Keep Up to Date – You will stay up to date with any legislative changes in regulatory affairs in drug and medical device industry, as our training courses are constantly monitored, reviewed and updated periodically. Even the latest regulatory changes are incorporated in the course.
• Learn from Industry Experts – The course content has been developed to ensure that you comply with regulatory legislation through the application of learning outcomes.