• Orphan Drug development provisions
• Data Exclusivity compared to the current legislation and its impact on pharmaceutical companies
• Regulatory provisions: EMA committees, assessment time, Platform technology approaches
• How can industry – and other stakeholders - prepare for implementation

In an increasingly regulated and data-driven industry, the digital transformation of Module 3 to align with PQ/CMC, IDMP, and ICH M4Q R2 standards is an important initiative and opportunity for pharmaceutical companies. This presentation will explore how industry expertise combined with advanced technologies, can enhance the reliability and trust (transparency, completeness, correctness, and timeliness). This will increase efficiency and accuracy during the creation, as well as the assessment of regulatory dossiers. By leveraging digital tools and technology-driven methodologies, pharmaceutical professionals can optimize their processes, reduce errors, and achieve better and faster decisions. The need in the pharmaceutical industry will be backed by recent industry survey results conducted by Celegence articulating some of the challenges and opportunities.

Participants will learn how to:

1. Apply best practices for streamlining Regulatory submissions -- how you can simplify and accelerate the preparation and submission of Module 3 documentation in compliance with PQ/CMC, IDMP, and ICH M4Q R2 guidelines

2. Enhance data integrity - utilizing digital solutions to ensure that data across systems and documents is consistent, reliable, and ready for regulatory scrutiny.

3. Navigate digital transformation challenges -- strategies for successfully implementing computer assisted assessments in the regulatory processes, including global regulatory impact assessment.

• With reliance being a consistent conversation, what progress has been made to date?
  • Which countries share reliance pathways?
  • Has this increased work sharing?
  • Are pathways more efficient?
• Wider impact
  • Industry's workload
  • Medicine availability
• Next steps for reliance

• Mapping out registration pathways for Covid-19 vaccines during pandemic, comparison of EMA, FDA, WHO and other global agencies approach
• Outlining core similarities and differences for the exceptional use pathways compared to standard ones
• Key steps and requirements for transition to standard authorisations

• EU AI Act Governance
• Preparation for implementation
  • Which stakeholders are involved?
  • Can industry get involved? And, if so, how?
• Potential implications for regulators, industry and wider public health

• Lessons learned from other industries
• How Regulatory sandboxes can help foster innovation

• Latest Advancements on reliance and convergence in APAC
  • Current available pathways by country
  • Comparison to other regional pathways
• Success story: utilising reliance for approval
• Lessons learned and future implications

• Latest regulatory updates for reliance pathways in the Middle East and Africa
  • Impact of such pathways on medicines available in the region
• Current experiences with using reliance pathways
  • Challenges and opportunities
  • On-going work
• Future plans for further development

• Exploration of staff views prior implementation
• Experience with CTR implementation, focusing on aspects such as:
  • Country requirements
  • Requests for information
  • The Q-IMPD only application

• What are the current environmental regulatory requirements for manufacturing and distributing pharmaceuticals in Europe?
• How are regulators and industry helping to reduce environmental impact?
  • Tracking carbon footprints of shipments, manufacturing, etc...
  • Limiting plastic use and increasing reusable materials
• Global initiatives focusing on sustainability
  • Ways to get involved
  • Upcoming projects

• Putting reliance principles into practice: Ins and outs of the WHO prequalification (PQ) and collaborative registration procedure (CRP)
• Industry experience with PQ and CRP

• Current alignment status of reliance pathways across LATAM
  • Comparison to other regions
  • Experiences with gaining approval
• Next steps: how can further alignment be achieved?

• The story behind the revision
• Updates in the framework
• Future outlook

• With legislative reforms on the horizon, how does the future look for pharmaceuticals in Europe?
  • Expectations on industry
  • Cross-regional harmonisation
  • Availability of medicines
• Future-proofing workforces
  • Which skills and tools do we expect to become more prevalent in the coming years?
  • Can industry and regulators alike prepare for these changes now?

• How does the concept of reliance filter into work sharing and collaboration?
  • Could cross-regional work sharing enhance medicine availability and reduce duplicated submission work?
• Future of the workforce
  • Preparing teams for enhanced collaboration
  • Organisational structuring for optimal working practices