4th Annual High Potent Medicines Conference (Rome, Italy - May 28-29, 2020) with Cross-Contamination Prevention Case Studies - ResearchAndMarkets.com

DUBLIN--()--The "4th Annual High Potent Medicines Conference" conference has been added to ResearchAndMarkets.com's offering.

The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer.

One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations.

This conference will address the challenges in the continual evolution of industry standards, technologies, and regulations. Leading experts from the industry will discuss the strategies for both in-house manufacturing and outsourcing by presenting expert keynote presentations, live case studies and breakthrough panel discussions.

Learn from 20+ industry-leading speakers who will be sharing their presentations on Challenges during the development of chemical processes of HPAPIs, Handling of highly potent products in a multi-product facility & Manufacturing Strategies for Highly Potent APIs.

The 2-day event will share the latest industry trends, advancements and future growth in the highly potent medicines market where leading industry experts will discuss the strategies for both pharma and CMO's.

Expert keynote presentations, live case studies, and breakthrough panel sessions on solutions to the challenges with regards to cleaning and validation in API Manufacturing and procedures to avoid cross-contamination.

Why Attend?

  • Utilizing the best practices to ensure the safe and efficient production of highly potent medicines
  • Training sessions on complex high potent compounds handling and containment issues
  • Understanding the updated regulatory guidelines in the HPAPI process
  • Implementing response plans to react to an unplanned event
  • Knowing the outsourcing strategies to effectively build a reliable supply chain

Key Highlights:

  • Process Development and Scale Up of HPAPIs
  • Risk Identification during Cleaning HPAPIs
  • Cross-Contamination Prevention Case Studies
  • Containment and Handling Strategies
  • Regulatory Landscape
  • Hazard Assessment Classifications

Agenda:

DAY ONE

  • Registration
  • Welcome note
  • Opening Remarks from the Chairman
  • Keynote Presentation: Manufacturing Strategies for Highly Potent APIs

PROCESS DEVELOPMENT AND SCALE UP OF HPAPI

  • Challenges during the development of chemical processes of HPAPIs - from lab to pilot plant scale
  • Morning Refreshments and Poster Presentation - One-to-One Networking Meetings
  • The development and manufacture of HPAPI drug products throughout the clinical phases
  • Solution Provider Presentation
  • ADCs requirements on high containment processing
  • Lunch and Poster Presentation - One-to-One Networking Meetings
  • Development and Manufacturing of Highly Potent APIs: from lab-scale to production scale
  • Making a successful outsourcing partnership

CONTAINMENT AND HANDLING STRATEGIES

  • Containment Equipment and Factors Affecting Containment Performance
  • Afternoon Refreshments and Poster Presentation - One-to-One Networking Meetings
  • Handling of highly potent products in a multi-product facility
  • Verifying the containment performance of pharmaceutical manufacturing and primary packaging equipment
  • Closing Remarks from the Chairman
  • Drinks Reception & Networking

DAY TWO

  • Registration
  • Welcome note
  • Opening Remarks from the Chairman
  • Keynote Presentation: Cleaning Validation in API Small Molecule

IDENTIFICATION OF RISKS DURING CLEANING HPAPI

  • Using banding approaches sensibly and appropriate use of cleaning limits
  • Morning Refreshments and Poster Presentation - One-to-One Networking Meetings
  • Solution Provider Presentation
  • Identification of high-risk products based on toxicological hazards for regulatory purposes
  • Prioritizing HPAPIs with respect to risks
  • Lunch and Poster Presentation - One-to-One Networking Meetings

OCCUPATIONAL TOXICOLOGY AND INDUSTRIAL HYGIENE

  • Applying occupational exposure limits on HPAPIs
  • Closing remarks from the Chairman

For more information about this conference visit https://www.researchandmarkets.com/r/2gigyg

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Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900