Biopharmaceutical Regulatory Affairs

This Biopharmaceutical Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of biopharmaceutical products. This online biopharmaceutical training course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel who are planning to join to already working in biotech pharmaceutical companies. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

Key features of the course

• 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
• Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
• Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page. 
• Moreover, final examination is online. Hence student can attend the final examination own convenient date and time. 

1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Few of the similar courses 

• Drug Biologic Medical Device Regulatory Affairs
• Biopharmaceutical Project Management
• Drug Regulatory Affairs
• Biopharma Medical Representative Training
• Pharma Strategic Management
• Drug Registration and Regulation in China
• GMP and GMP audit training
• Valuation technique in biotech industry
• Basics of biopharmaceutical
• Pharma Business Development and Licensing

Career in Biopharmaceutical Regulatory Affairs

The biopharma sector has seen high growth in last 10 years, and most importantly this high growth is going to sustain, even in next 15 years. Due to drying up drug (chemical) pipeline, patent expiry, traditional pharmaceutical companies, who are focussing on small molecules, are now looking for the strategic options to keep up their revenue projection.

Hence, a lot of pharmaceutical companies are diversifying to biopharmaceutical segment. Moreover, many patented biologics are going to expire in coming days, biosimilar is seen as a big scope for pharmaceutical and pharmaceutical companies. Way back in year 1990, total annual revenue of biopharmaceutical industry was has increased from about $4.4 billion. However, biopharma industry reached $275 billion. Most importantly, Biopharmaceutical industry is contributing more than 25 percent of the total pharmaceutical market.

So, there will be huge job demand in biopharmaceutical market. Therefore, biopharma industry seeks skilled person who knows about the basics of  biopharmaceuticals. In addition, advance knowledge about the biopharmaceutical regulation will be required for strategic management, business development and regulatory personnel.

What regulatory job involves?

A career in Biopharmaceutical and Bisomilar 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.

Important Articles

Biopharma Basics

• Introduction to Global biopharmaceutical Industry.
• Biotech Drug Development Process. Overview of the development of a biotech product – clarify the difference between synthetic drugs, biologics and biotech products.
• Biotech Drugs Classification. Important classes.
• Detailed understanding on different types biologics. For example, Monoclonal Antibody, Interferon, Erythropoiesis Stimulating Agents and other important biologic.
• Key Understanding on biotech regulation. Topics include understanding the differences in regulatory philosophy between small molecules and biotech product regulation.
• Preclinical and Clinical Research Design.

Regulatory Pathway

• Innovator biopharmaceutical regulation, registration process.
• Biosimilar Development and regulation. Topics include Introduction to Biosimilar. Meaning of Biosimilar vs. Follow on biologics. Subsequently Difference between biosimilar and generic drugs. Key important issues in Biotech and biosimilar product manufacturing. Insight on biosimilar approval pathway.

Advance Strategic Management 

• Topics include regulatory submission, approval, production, and the postmarket environment for both drugs and devices. Challenges surrounding the approval and naming of follow-on biologics are addressed. Above all, course discussion covers the stages of a drug pipeline and risk assessment at each marketing authorization stages.
• Analytical techniques for the Biotech Drugs. Understand the need for using a range of analytical methods in the characterization of biotech product.
• Global Biotechnology Business. Discussion also covers domestic and International business considerations and international regulatory requirements. Moreover, course provide the access to case studies related to biopahrmaceutical strategic management.