Biologic Regulatory Affairs [PG Certification]

This Biologic Regulatory Affairs online course utilizes interactive e-learning tools. Hence, this provides seamless practical learning experience.

This online biologic 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 biologic manufacturing and marketing 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.

Who should attend the course?

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 Regulatory Affairs department in a biologic company

A career in biologic regulatory affairs involves working in a field that focuses on ensuring compliance with regulations and guidelines related to the development, approval, and post-marketing activities of biologic products. Biologic products include vaccines, gene therapies, blood products, and other treatments derived from living organisms.

Role and Key Responsibilities of the Biologic Regulatory Affairs professional

Regulatory Compliance

Regulatory affairs professionals in the biologic industry are responsible for understanding and interpreting regulations and guidelines set forth by regulatory authorities. They ensure that biologic products and their associated documentation meet all necessary requirements.

Product Registration and Approval

Regulatory affairs professionals play a crucial role in the submission and approval process for biologic products. They prepare and submit regulatory applications, including investigational new drug (IND) applications, biologics license applications (BLAs), and marketing authorization applications (MAAs). They work closely with cross-functional teams, including researchers, clinicians, and manufacturing experts, to gather and compile the necessary data and documentation for submissions.

Regulatory Strategy

There is no doubt of the fact that Developing a regulatory strategy is an important aspect of regulatory affairs. Certainly, professionals in this field provide strategic guidance to ensure that product development plans align with regulatory requirements. For instance, they assess the regulatory landscape, anticipate potential challenges first. Further they will develop strategies to address them. Hence, this involves staying up to date with the latest regulatory developments and industry trends.

Labeling and Advertising

Regulatory affairs professionals ensure that product labeling and advertising materials comply with regulatory guidelines. For instance, they are responsible for review and approve labeling content, including package inserts, patient information leaflets, and promotional materials. Therefore this will ensure accuracy and compliance of the biologics.

Post-Marketing Compliance

Once a biologic product is approved and on the market, regulatory affairs professionals monitor post-marketing activities to ensure ongoing compliance with regulatory requirements. In fact they manage post-approval submissions, track adverse events. In addition, they ensure timely reporting to regulatory authorities. They also stay updated on changes to regulations and guidelines that may impact post-marketing activities.

Liaison with Regulatory Authorities

Above all, regulatory affairs professionals serve as a point of contact between the biologic company and regulatory authorities. They may participate in meetings with regulatory agencies, address queries or requests for additional information, and represent the company’s interests during regulatory inspections or audits.

Qualification and skill required for Biologic Regulatory Affairs Professionals

• To pursue a career in biologic regulatory affairs, a background in life sciences, pharmacy, or a related field is typically required.
• Many regulatory affairs professionals also hold advanced degrees, such as a Master’s or even higher.
• Above all, strong attention to detail, knowledge of regulatory guidelines, excellent communication skills, and the ability to work in cross-functional teams are important qualities for success in this field.
• In fact, PG Certification Biologic regulatory affairs (PGBRA) course will enhance your acceptance of your candidature as the course provides hands on training on Biologic and Biosimilar regulation, registration and strategic planning process.

Periodic update is the key for Biologic Regulatory professionals

• Above all, biologic regulations and requirements can vary between countries and regions. Therefore, familiarity with the specific regulatory environment of the target market is essential. Additionally, staying up to date with evolving regulations and guidelines is crucial to effectively navigate the dynamic regulatory landscape in the biologic industry. In this regard, PG Certification Biologic regulatory affairs (PGBRA) plays a forehand role to keep user informed about the changing guideline of biologic industry.

Some Important Articles

• What is the major difference between biosimilar and interchangeable biological products?
• List of USFDA approved Biosimilar [till date]
• What is Biologic License Application (BLA)?
• USFDA Biosimilar Approval : 4 Biosimilar total and 3 new approval of biosimilar in 2016
• Significance of Purple Book
• 351(k) biologics license application

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.
• Advanced Therapy Medicinal Products (ATMPs).
• 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.
• Biosimilar Approval Pathways
• Key important issues in Biotech and biosimilar product manufacturing. Insight on biosimilar approval pathway.

Biologic CMC writing and management 

• Biologics Product Characteristics and Regulatory Implications
• Quality By Design
• QbD and TPP
• Comparability of biologic products
• CMC strategic planning for various types of the biologics
• Documentation requirements

Biologic Manufacturing 

• GMP requirements for Biologic Products.
• Biologic and Biosimilar manufacturing process.
• Plant audits, warning letters, CRL.

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 biologic strategic management.

Country specific guidelines

• Biologic regulations in US, EU, LATAM, Middle East / GCC, LATAM, Japan, ASEAN, India and ROW market.