Drug Regulatory Affairs and Pharmacovigilance [Dual Specialization]

Who should attend this course? 

• Professionals working in Regulatory Affairs, Pharmacovigilance, Drug Safety, Compliance, Clinical Ops, Quality Assurance who want to deepen their knowledge across both domains.
• Life-sciences graduates (Pharmacy, Biotechnology, Life Science, Chemistry) or those aspiring to enter the regulatory or PV function.
• Individuals wishing to upgrade their skills to include emerging areas like AI, RWD/RWE and healthcare-data management in the pharma/biopharma domain.
• Corporate teams in pharma/biopharma who want cross-functional capability in regulatory strategy + safety + data-driven decision-making.

Learning Outcome

By the end of the programme you will be able to:

• Understand the full lifecycle of drug development —from discovery through to post-market safety monitoring.
• Apply global regulatory frameworks (US, EU, India, MENA, ASEAN) and handle dossier preparation/submission/variation.
• Design and implement pharmacovigilance systems: case processing, signal detection, aggregate reporting, risk management.
• Leverage RWD to generate RWE and apply it in regulatory submissions, safety assessments and lifecycle strategy.
• Use AI tools and techniques in regulatory affairs and pharmacovigilance workflows — e.g., document automation, predictive analytics, database mining.
• Manage and analyse healthcare and safety databases, integrate RWD sources, ensure data quality and governance.
• Simulate real-job scenarios in regulatory affairs & pharmacovigilance to improve decision-making and strategic planning.

• Combines two highly sought-after fields — Regulatory Affairs + Pharmacovigilance — into one programme, giving you versatility and enhanced employability. 
• The updated focus on AI, RWD/RWE and healthcare database analytics brings you into the frontier of the industry where regulatory and safety decisions are increasingly data-driven.
• Real-life simulations and case studies prepare you not just theoretically but practically for job roles across pharma/biopharma.
• Online self-paced format allows flexibility for working professionals.

Few of the similar courses

• International Drug Regulatory Affairs
• Drug Biologic Medical Device Regulatory Affairs
• Pharmacovigilance
• US Pharmaceutical and Biopharmaceutical Regulatory Affairs
• Japan Drug Regulatory Affairs
• Drug Registration and Regulation in China
• Drug Discovery and Development to Commercialization
• European Drug Regulatory Affairs
• Drug Registration and Regulation in GCC countries
• UAE Drug Regulation and Registration
• Drug Registration and Regulation in Saudi Arabia
• Middle East Drug Regulatory Affairs

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The Pharma and biopharma industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Hence, the major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. In fact, to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Australia, NMPA – China etc. all over the world are imposing number of regulation. Therefore, these regulations are evolving and changing every other day. Most importantly, regulatory professionals must have thorough knowledge about the updated regulations. Certainly, sound regulatory knowledge helps them to take strategic decision effectively. Hence, this has resulted in creation of regulatory department with certified regulatory affairs professionals. Therefore, it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

Career in Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Pharmacovigilance deals with 4 important aspects. Adverse Event Case Management including expedited reporting, Aggregate Reporting, Signal Intelligence; and Risk Management. A professionals should have excellent understanding on these aspects. The aims of pharmacovigilance within the industry are essentially the same as those of regulatory agencies; that is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit. Although the perspectives of companies and the regulatory agencies may be different they now work more and more closely together and share information. However, central pharmacovigilance units in major pharmaceutical companies in many instances are far better resourced and have much greater ‘in-house’ expertise on the safety of their particular products.

What is the advantage of ours Regulatory Affairs and Pharmacovigilane dual course?

Royed Training’s dual specialization course in Drug Regulatory Affairs and Pharmacovigilance provides a comprehensive education that prepares students for critical roles in the pharmaceutical industry. Therefore, by integrating these two essential areas into a single program, students gain a robust understanding of both the regulatory requirements necessary for bringing drugs to market and the ongoing safety monitoring required post-approval. Moreover, this dual focus equips graduates with the skills to navigate complex regulatory landscapes, ensure compliance, and maintain high safety standards, making them highly valuable to employers. Additionally, the course’s broad scope enhances career versatility, allowing graduates to pursue diverse opportunities within the fields of regulatory affairs and pharmacovigilance.