9th Annual MarketsandMarkets

High Potent Medicines Conference - EU Edition

22nd - 24th May 2024

NH Milano Congress Centre. Strada 2, 7, 20057 Assago MI, Italy

Welcome to the MarketsandMarkets 9th High Potent Medicines Conference– 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

  • 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

Dean Calhoun , President, CEO, Affygility Soultions, USA

09:05 - 09:10

Keynote Presentation

Dean Calhoun

Dean Calhoun , President, CEO, Affygility Soultions, USA

09:10 - 09:45

Process equipment special design for HPAPI containment system integration

Stefano Butti

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

Sean Codling , Managing Director , CTS Europe

11:10 - 11:45

Single-Use Containment Solutions for HPAPI Handling and Tabletting Process

Michael Schweizer

Michael Schweizer, Head of Sales, Lugaia AG, Switzerland

11:45 - 12:20

Safety & efficiency: High containment filter solutions

Christopher Muschiol

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

Thomas Adam, Head of Global Quality Assurance Chemical APIs, , Bayer, Germany

14:00 - 14:35

HPAPIs Facilities design

Andrea Messori

Andrea Messori , Lead Process Engineer-Project & Engineering Manager, Process Service

14:35 - 15:10

Manufacturing of Oncological Products by a CDMO

Fabio Zenobi

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

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

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

Christian Dunne, Director, Global Corporate Business Development, ChargePoint Technology, UK

09:10 - 09:45

Elements of a Comprehensive Potent Compound Safety Programme

Tara Dennis

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

William Hawkins, Managing Toxicologist, SafeBridge Europe

11:10 - 11:45

Cleaning validation

Hagar Mohamed

Hagar Mohamed, Production Specialist, Novartis, Egypt

11:45 - 12:20

Containment design in a OEB5 Facility

Pietro Virgilio

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

Dean Calhoun , President, CEO, Affygility Soultions, USA

Andrea Messori

Andrea Messori , Lead Process Engineer-Project & Engineering Manager, Process Service

Sean Codling

Sean Codling , Managing Director , CTS Europe

Pietro Virgilio

Pietro Virgilio , Process Design Containment, Exyte, Italy

13:55 - 14:30

Closing remarks from the Chairman

Dean Calhoun

Dean Calhoun , President, CEO, Affygility Soultions, USA

14:30 - 14:35

End of Conference

14:35 - 14:35

SPEAKERS

Fabio Zenobi

Fabio Zenobi

EHS Director, BSP Pharmaceuticals, Italy

Stefano Butti

Stefano Butti

Sales Director, FPS

Dean Calhoun

Dean Calhoun

President, CEO, Affygility Soultions, USA

Tara Dennis

Tara Dennis

Occupational Hygiene Manager, SafeBridge

William Hawkins

William Hawkins

Managing Toxicologist, SafeBridge Europe

Thomas Adam

Thomas Adam

Head of Global Quality Assurance Chemical APIs, , Bayer, Germany

Sean Codling

Sean Codling

Managing Director , CTS Europe

Andrea Messori

Andrea Messori

Lead Process Engineer-Project & Engineering Manager, Process Service

Christopher Muschiol

Christopher Muschiol

Chief Revenue Officer, HET Filter GmbH, Germany

Michael Schweizer

Michael Schweizer

Head of Sales, Lugaia AG, Switzerland

John Stevens

John Stevens

Field Marketing Manager, Merck KGaA

Hagar Mohamed

Hagar Mohamed

Production Specialist, Novartis, Egypt

Filippo Saleri

Filippo Saleri

Subject Matter Expert CMO, Ferring Pharmaceuticals

Christian Dunne

Christian Dunne

Director, Global Corporate Business Development, ChargePoint Technology, UK

Pietro Virgilio

Pietro Virgilio

Process Design Containment, Exyte, Italy

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LOCATION

Venue

NH Milano Congress Centre. Strada 2, 7, 20057 Assago MI, Italy

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