Drug Regulatory Affairs and Pharmacovigilance

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.

Advanced Diploma in Drug Regulatory Affairs and Pharmacovigilance course provides comprehensive training on drug regulatory affairs and pharmacovigilance under the 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. 

Pharmacovigilance Topics 

The course has been designed and tailored specifically to the needs of pharmacovigilance learning from practical point of view.

The Overview of Pharmacovigilance & Drug Safety course gives you a good understanding of the basic to advanced principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management.

Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

• Introduction to Clinical Research and Pharmacovigilance
• Global Pharmacovigilance System
• Sources and Documentation of Individual Case Safety Reports (ICSRs)
• Case processing and Reporting
• Medical dictionary (MedDRA) and Medical aspects in Pharmacovigilance
• Special cases in Pharmacovigilance
• Medical Information System
• Safety monitoring in Clinical Trials
• Signal detection
• Periodic Safety Update Reports (PSURs)
• Risk –benefit assessment and management in Pharmacovigilance
• Standard operating procedures in Pharmacovigilance
• Compliance monitoring and Pharmacovigilance inspections
• Global regulatory requirements and guidelines in Pharmacovigilance
• Pharmacovigilance communications
• Pharmacoepidemiology

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 regulatory affairs and pharmacovigilance 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 and pharmacovigilance 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 and pharmacovigilance legislation through the application of learning outcomes.