Regulatory Strategies for Biologics and Biosimilars

Length: 2 days

Regulatory Strategies for Biologics and Biosimilars

The “Regulatory Strategies for Biologics and Biosimilars” training course by Tonex provides an in-depth exploration of the regulatory landscape governing the development, approval, and post-market surveillance of biologics and biosimilars.

This course is designed to equip professionals with the knowledge and skills needed to navigate complex regulatory requirements and ensure compliance with global standards.

Participants will gain insights into the latest regulatory updates, strategic planning for regulatory submissions, and best practices for maintaining regulatory compliance throughout the product lifecycle.

Learning Objectives

By the end of this training course, participants will be able to:

  • Understand the regulatory framework for biologics and biosimilars in key global markets.
  • Develop strategic plans for regulatory submissions and approvals.
  • Identify and address key regulatory challenges and opportunities in the development of biologics and biosimilars.
  • Implement best practices for compliance with regulatory requirements throughout the product lifecycle.
  • Navigate the regulatory pathways for market entry and post-market surveillance.
  • Interpret and apply the latest regulatory updates and guidelines to their organizations.

Audience

This course is ideal for:

  • Regulatory affairs professionals
  • Quality assurance and compliance specialists
  • Research and development scientists
  • Clinical trial managers
  • Biotechnology and pharmaceutical executives
  • Legal and policy advisors in the biotech and pharma industries

Program Modules

Module 1: Introduction to Biologics and Biosimilars

  • Definitions and classifications
  • Historical development and market trends
  • Key differences between biologics and biosimilars
  • Overview of therapeutic applications
  • Biotechnological principles and production
  • Regulatory considerations

Module 2: Global Regulatory Frameworks

  • FDA regulations and guidance
  • European Medicines Agency (EMA) standards
  • Regulations in Asia-Pacific regions
  • WHO guidelines and global harmonization efforts
  • Comparative analysis of regulatory pathways
  • Case studies of successful approvals

Module 3: Strategic Regulatory Planning

  • Preparing regulatory submissions
  • Data requirements for biologics and biosimilars
  • Regulatory strategies for clinical trials
  • Interactions with regulatory agencies
  • Managing regulatory timelines and milestones
  • Risk management and mitigation

Module 4: Quality and Compliance

  • Good Manufacturing Practices (GMP) for biologics
  • Quality by Design (QbD) principles
  • Ensuring product safety, efficacy, and consistency
  • Regulatory inspections and audits
  • Post-market surveillance and pharmacovigilance
  • Handling regulatory non-compliance issues

Module 5: Regulatory Challenges and Solutions

  • Addressing scientific and technical challenges
  • Patent and exclusivity considerations
  • Biosimilarity and interchangeability assessments
  • Labeling and advertising regulations
  • Managing regulatory changes and updates
  • Case studies of regulatory challenges

Module 6: Future Trends and Developments

  • Emerging regulatory trends and innovations
  • Impact of new technologies on regulatory strategies
  • Personalized medicine and regulatory implications
  • Global market access strategies
  • Regulatory aspects of digital health in biologics
  • Predictive analytics and regulatory science

This comprehensive training course will empower participants with the critical regulatory knowledge and strategic insights needed to successfully navigate the evolving landscape of biologics and biosimilars.