Name: 9th Annual MarketsandMarkets High Potent Medicines Conference - EU Edition
Start: 2024-05-22
End: 2024-05-24
Location: NH Milano Congress Centre. Strada 2, 7, 20057 Assago MI, Italy

WHAT TO EXPECT

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

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

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

CONFERENCE AGENDA

Registration	08:15 - 09:05
Opening Remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	09:05 - 09:10
Keynote Presentation Dean Calhoun , President, CEO, Affygility Soultions, USA	09:10 - 09:45
Process equipment special design for HPAPI containment system integration Stefano Butti , Sales Director, FPS	09:45 - 10:20
Morning Refreshments \| One-to-One Networking Meetings	10:20 - 11:10
Containment Challenges in The Laboratory Sean Codling , Managing Director , CTS Europe	11:10 - 11:45
Single-Use Containment Solutions for HPAPI Handling and Tabletting Process Michael Schweizer, Head of Sales, Lugaia AG, Switzerland	11:45 - 12:20
Safety & efficiency: High containment filter solutions Christopher Muschiol, Chief Revenue Officer, HET Filter GmbH, Germany	12:20 - 12:55
Lunch \| One-to-One Networking Meetings	12:55 - 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 - 14:35
HPAPIs Facilities design Andrea Messori , Lead Process Engineer-Project & Engineering Manager, Process Service	14:35 - 15:10
Manufacturing of Oncological Products by a CDMO Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy	15:10 - 15:45
Afternoon Refreshments and Poster Presentation \| One-to-One Networking Meetings	15:45 - 16:30
Chasing the Nanogram Limit – Meeting New Safety Thresholds for HPAPI Containment John Stevens, Field Marketing Manager, Merck KGaA	16:30 - 17:05
Closing Remarks from the Chairman	17:05 - 17:10
Drinks Reception & Networking	17:10 - 17:10

Registration	08:15 - 09:05
Opening Remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	09:05 - 09:10
Keynote Presentation-High containment and Sterile transfers (Case Study – High containment / Sterile Formulation – Ritedose Corporation) Christian Dunne, Director, Global Corporate Business Development, ChargePoint Technology, UK	09:10 - 09:45
Elements of a Comprehensive Potent Compound Safety Programme Tara Dennis, Occupational Hygiene Manager, SafeBridge	09:45 - 10:20
Morning Refreshments \| One-to-One Networking Meetings	10:20 - 11:10
Permitted Daily Exposure (PDE) for Cleaning Validation William Hawkins, Managing Toxicologist, SafeBridge Europe	11:10 - 11:45
Cleaning validation Hagar Mohamed, Production Specialist, Novartis, Egypt	11:45 - 12:20
Containment design in a OEB5 Facility Pietro Virgilio , Process Design Containment, Exyte, Italy	12:20 - 12:55
Lunch \| One-to-One Networking Meetings	12:55 - 13:55
Panel Discussion: Redefining Safety Standards for HPAPIs: Should existing safety protocols for HPAPIs be considered inadequate? A debate on whether current containment and safety measures are sufficient or if they need an overhaul to keep up with new HPAPI complexities. Dean Calhoun , President, CEO, Affygility Soultions, USA Andrea Messori , Lead Process Engineer-Project & Engineering Manager, Process Service Sean Codling , Managing Director , CTS Europe Pietro Virgilio , Process Design Containment, Exyte, Italy	13:55 - 14:30
Closing remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	14:30 - 14:35
End of Conference	14:35 - 14:35