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 - 09:00

Welcome note from MarketsandMarkets

09:00 - 09:05

Opening Remarks from the Chairman

09:05 - 09:10

Keynote Presentation

Dean Calhoun

Dean Calhoun , President, CEO, Affygility Soultions, USA

09:10 - 09:40

Process equipment special design for HPAPI containment system integration

Stefano Butti

Stefano Butti , Sales Director, FPS

09:40 - 10:10

Morning Refreshments and Poster Presentation | One-to-One Networking Meetings

10:10 - 11:00

Containment Challenges in The Laboratory

Sean Codling

Sean Codling , Managing Director , CTS Europe

11:00 - 11:30

Efficient Handling of high-potent APIs – a CDMO perspective

11:30 - 12:00

Safety & efficiency: High containment filter solutions

Christopher Muschiol

Christopher Muschiol, Chief Revenue Officer, HET Filter GmbH, Germany

12:00 - 12:30

Single-Use Containment Solutions for HPAPI Handling and Tabletting Process

Michael Schweizer

Michael Schweizer, Head of Sales, Lugaia AG, Switzerland

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

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

14:00 - 14:30

HPAPIs Facilities design

Andrea Messori

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

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

Chasing the Nanogram Limit – Meeting New Safety Thresholds for HPAPI Containment

John Stevens

John Stevens, Field Marketing Manager, MilliporeSigma, USA

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

Registration

08:15 - 09:00

Welcome note from MarketsandMarkets

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

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, MilliporeSigma, USA

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LOCATION

Venue

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

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