The 9th High Potent Medicines Conference is the premier gathering for pioneers and experts in the realm of Highly Potent Active Pharmaceutical Ingredients (HPAPIs). This transformative event converges industry leaders and regulatory professionals on a singular platform dedicated to exploring cutting-edge developments in the development, manufacturing, and safe handling of highly potent compounds.
Engage with real-world experiences and case studies from companies at the forefront of successful HPAPI programs. Learn from challenges, uncover best practices and pioneering strategies in containment technologies, risk assessment, and occupational health and safety that are shaping the industry's approach to safety, quality control, and regulatory compliance in effective HPAPI manufacturing.
WHAT TO EXPECT
Key Highlights
- Technology transfer and scale up of HPAPI’s
- Right CDMO selection and partnership
- Containment and handling of HPAPI’s
- Cleaning validation and risk mitigation
- Regulatory landscape and compliance
- Occupational Health and Safety
Why Attend?
- Utilizing the best practices to ensure safe and efficient production of high 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
Agenda
Day 1: Wednesday 22nd May, 2024
- Registration: 08:15 - 09:00
- Welcome note: 09:00 - 09:05
- Opening Remarks from the Chairman: 09:05 - 09:10
- Keynote Presentation: Dean Calhoun, President, CEO, Affygility Soultions, USA: 09:10 - 09:40
- Implementation of ISPE’s Good Practice Guide on Containment for Potent Compounds - Key Points for Consideration: 09:40 - 10:10
- Morning Refreshments and Poster Presentation | One-to-One Networking Meetings: 10:10 - 11:00
- Keys to effective onboarding of new compounds at CDMOs: 11:00 - 11:30
- Efficient Handling of high-potent APIs - a CDMO perspective: 11:30 - 12:00
- Assessing the effectiveness of containment solutions in reducing the risk of cross-contamination: 12:00 - 12:30
- Solution Provider Presentation: 12:30 - 13:00
- Lunch and Poster Presentation | One-to-One Networking Meetings: 13:00 - 14:00
- HPAPI Handling from Lab Bench to Pilot Plant within Chemical Development (case studies)
- Thomas Adam, Head of Global Quality Assurance Chemical APIs,, Bayer, Germany: 14:00 - 14:30
- Smart manufacturing solutions for quality and efficiency improvement: 14:30 - 15:00
- Solution Provider Presentation: 15:00 - 15:30
- Afternoon Refreshments and Poster Presentation | One-to-One Networking Meetings: 15:30 - 16:15
- Solution Provider Presentation: 16:15 - 16:45
- Panel Discussion: CDMO Strategy key to HPAPI success-Navigating challenges in HPAPI development and choosing the right CDMO: 16:45 - 17:15
- Closing Remarks from the Chairman: 17:15 - 17:20
- Drinks Reception & Networking: 17:20 - 17:20
Day 2: Thursday 23rd May, 2024
- Registration: 08:15 - 09:00
- Welcome note: 09:00 - 09:05
- Opening Remarks from the Chairman: 09:05 - 09:10
- Keynote Presentation: 09:10 - 09:40
- Considerations for the environmental impact of manufacturing HPAPIs and sustainable practices: 09:40 - 10:10
- Morning Refreshments and Poster Presentation | One-to-One Networking Meetings: 10:10 - 11:00
- Challenges and solutions in PPE compliance: 11:00 - 11:30
- Regulatory perspectives on OELs and their impact on manufacturing practices: 11:30 - 12:00
- Risk-based approaches to establishing OELs: 12:00 - 12:30
- Solution Provider Slot: 12:30 - 13:00
- Lunch and Poster Presentation | One-to-One Networking Meetings: 13:00 - 14:00
- Implementing ongoing monitoring programs to verify the effectiveness of cleaning processes: 14:00 - 14:30
- Validating the cleaning efficacy of fixed and portable cleaning equipment: 14:30 - 15:00
- Closing remarks from the Chairman: 15:00 - 15:05
- End of Conference: 15:05 - 15:05
Day 3: Friday 24th May, 2024
- 08:00 - 9.30 Transfer from Hotel to FPS factory
- 9.30 - 9.45 Registration and coffee break
- 9:45 - 10:00 Welcome introduction
- 10:00 - 10:30 SESSION 1: Containment projects Milestones
- 10:30 - 10:45 Q&A
- 10:45 - 11:15 SESSION 2: High containment system routine and preventative maintenance
- 11:15 - 11:30 Q&A
- 11:30 - 11:45 Coffee break
- 11:45 - 12:15 SESSION 3: Containment performance verification
- 12:15 - 12:30 Q&A
- 12:45 - 14:00 Lunch break/buffet
- 14:00 - 16:00 Afternoon session into groups:
- Split Butterfly valves live DEMO
- Rapid Transfer Ports live DEMO
- Isolator live DEMO
- FPS company tour
- 16:00 - 16:15 Final notes
- 16:15 Transfer to Hote
Speakers
Fabio Zenobi
EHS Director, BSP Pharmaceuticals, Italy
Stefano Butti
Sales Director, FPS
Dean Calhoun
President, CEO, Affygility Soultions, USA
Tara Dennis
Occupational Hygiene Manager, SafeBridge
William Hawkins
Managing Toxicologist, SafeBridge Europe
Thomas Adam
Head of Global Quality Assurance Chemical APIs, Bayer, Germany
Sean Codling
Managing Director, CTS Europe
Andrea Messori
Lead Process Engineer-Project & Engineering Manager, Process Service
Christopher Muschiol
Chief Revenue Officer, HET Filter GmbH, Germany
Michael Schweizer
Head of Sales, Lugaia AG, Switzerland
John Stevens
Field Marketing Manager, MilliporeSigma, USA
Who Should Attend
From pharmaceutical and Biopharmaceutical manufacturing:
Chief executives, VP’s, Directors, Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Toxicologists, Fellows, Investigators working in:
- Research & Development
- Manufacturing/Operations/Production
- Maintenance
- Engineering
- Risk Assessments
- Laboratory Services/Analytical
- New Technologies
- Process Development/Technical transfer
- Environmental, Health & Safety (HSE)
- Occupational Toxicology
- Industrial Hygiene
- New Products
- Product Quality
- Regulatory
- Validation
- Formulation Development
Location
ADDRESS
Milian
Italy
Venue to be announced shortly.
