Regulatory Trends in HPAPI: Navigating Compliance in a Dynamic Landscape

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Join the EuroPotent Therapeutics Summit 2025 to explore HPAPI development, manufacturing, regulatory updates, containment strategies, and industry collaborations.

The EuroPotent Therapeutics Summit, organized by Veridon Global, is scheduled for May 22–23, 2025, in Frankfurt, Germany. This premier event aims to unite leading experts, innovators, and decision-makers in the field of high-potency active pharmaceutical ingredients (HPAPI) and potent therapeutic development.

Key Themes and Topics

The summit will delve into several critical areas pertinent to HPAPI development and manufacturing, including:

  • Navigating EU Regulations: A comprehensive overview of the evolving European regulatory landscape, focusing on compliance challenges in HPAPI manufacturing, containment, and transportation.

  • Advanced Containment Strategies: Exploration of cutting-edge containment and isolation technologies to ensure safety and compliance in HPAPI facilities.

  • Supply Chain Resilience: Strategies to strengthen the supply chain for high-potency APIs within Europe, ensuring reliability and efficiency.

  • Technological Integration: Utilizing machine learning and process analytical technology (PAT) for precision in HPAPI production, optimizing processes while maintaining safety standards.

  • Environmental Sustainability: Discussions on waste management and sustainable practices in HPAPI production to minimize environmental impact.

  • Risk Assessment: Best practices for assessing and mitigating risks associated with high-potency substances in European facilities.

  • Collaborations with CMOs: Insights into effective partnerships with Contract Manufacturing Organizations (CMOs) in Europe to enhance HPAPI development and manufacturing.

Who Should Attend?

The EuroPotent Therapeutics Summit is designed for professionals in the pharmaceutical and biotechnology industries involved in the development, production, and regulation of HPAPIs. Key attendees include:

  • HPAPI Production Managers/Heads

  • Process Development Engineers

  • Regulatory Affairs Managers/Heads

  • Research and Development Managers/Heads

  • Quality Assurance and Control Professionals

  • Occupational Safety and Health (HSE/EHS) Professionals

  • Supply Chain Managers/Heads

  • Pharmaceutical Consultants

Why Attend?

Participants will gain valuable insights into the latest advancements in HPAPI development and manufacturing, including:

  • Regulatory updates and compliance strategies specific to Europe.

  • Innovative containment and isolation technologies.

  • Integration of digital tools to optimize production processes.

  • Environmental sustainability practices in HPAPI production.

  • Risk assessment methodologies for high-potency substances.

  • Best practices for collaborating with European CMOs.

The summit will feature a combination of case studies and panel discussions, providing practical insights into overcoming the complexities of handling potent compounds and achieving operational excellence in a highly regulated market. By fostering collaboration and knowledge exchange, the event aims to empower stakeholders to tackle the challenges of HPAPI production, develop effective strategies for the future, and strengthen their competitive edge in the European market.

For detailed information on registration fees and to secure your place at the summit here https://veridonglobal.com/events/europotent-therapeutics-summit/register-europotent/

Don’t miss this opportunity to connect with industry leaders and stay at the forefront of HPAPI development and manufacturing.

Regulatory Trends in HPAPI: Navigating Compliance in a Dynamic Landscape
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