4th Annual MarketsandMarkets

High Potent Medicines Virtual Conference ( Time Zone - CENTRAL EUROPEAN TIME (CET)

14th - 15th September 2020

20+

Speaker

10+

Networking Hours

4+

Sessions

150+

Attendees

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. 

MarketsandMarkets is proud to announce the 4th Annual High Potent Medicines Conference to be held on 14th - 15th September 2020 . This conference would 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.

Tag Line
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 API’s  
Tag Line
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
Tag Line
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

WHAT TO EXPECT

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

  • Chief executives
  • VP’s
  • Directors
  • Heads
  • Leaders
  • Senior Managers
  • Principal Scientists
  • Principal Toxicologists
  • Toxicologists
  • Fellows
  • Investigators

  • Research & Development
  • Manufacturing/Operations
  • Maintenance
  • Engineering
  • Risk Assessments
  • Laboratory Services/Analytical
  • New Technologies
  • Process Development/Technical transfer
  • Environmental, Health & Safety
  • Occupational Toxicology
  • Industrial Hygiene
  • New Products
  • Product Quality
  • Regulatory
  • Validation
  • Formulation Development

CONFERENCE AGENDA

Registration

14:30 - 14:50

Welcome note from MarketsandMarkets

14:50 - 14:55

Opening Remarks from the Chairman

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

14:55 - 15:00

Keynote Presentation: Cleaning validation as one driver to prevent cross-contamination

Andreas Schreiner

Andreas Schreiner , Head of Validation, Novartis, Switzerland

15:00 - 15:35

PROCESS DEVELOPMENT AND SCALE UP OF HPAPIS

Managing the challenge of cross-contamination: pharmaceutical and cosmetic semi-solids side by side

Ildiko Ziegler

Ildiko Ziegler, Quality Assurance Manager, Vanessa Research

15:35 - 16:10

The safe house for your HPAPIs

 Jacopo Buzzanca

Jacopo Buzzanca, Custom Synthesis Manager , Angelini Pharma, Italy

16:10 - 16:45

HPAPI isolator with integrated process equipment, from R&D to production scale

Stefano Butti

Stefano Butti , Sales Director, FPS

16:45 - 17:20

Manufacturing of Oncological Products by a CDMO

Fabio Zenobi

Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy

17:20 - 17:55

CONTAINMENT AND HANDLING STRATEGIES

How to handle HPAPIs in chemical Development (case studies)

Thomas Adam

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

17:55 - 18:30

How to achieve and maintain high containment in a multi-process plant

18:30 - 19:05

GMP and Occupational Requirements for Aseptic Processing of high potent substances

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

19:05 - 19:40

Closing Remarks from the Chairman

19:40 - 19:45

Registration

14:30 - 14:50

Welcome note from MarketsandMarkets

14:50 - 14:55

Opening Remarks from the Chairman

Richard Denk

Richard Denk , Head Containment, SKAN AG, Switzerland

14:55 - 15:00

Keynote Presentation: Regulatory updates in Health based exposure limits (HBELs)

Ester Lovsin Barle

Ester Lovsin Barle , Head, Product Stewardship and Health, Takeda, Switzerland

15:00 - 15:35

IDENTIFICATION OF RISKS DURING CLEANING HPAPI’S AND REGULATORY UPDATES

Getting a good health-based exposure limits (HBELs)

Martin Kohan

Martin Kohan, Senior Occupational Toxicologist, SafeBridge

15:35 - 16:10

Assessing Containment Performance of Innovative Table Coating Equipment

Martin Axon

Martin Axon, Senior Principal Occupational Hygienist , SafeBridge Europe

16:10 - 16:45

High Potent Drug Product Facility and Operation, ‘Best Practice’:

Jerome Detreille

Jerome Detreille , Senior Director, New Business Development, PCI Services, UK

16:45 - 17:20

Containment HPAPI Handling Processing Strategy Best Practices

Yossi Shapira

Yossi Shapira , Associate Director, MS&T S.M.E Teva Pharmaceuticals

17:20 - 18:10

Closing remarks from the Chairman

18:10 - 18:15

SPEAKERS

Richard Denk

Richard Denk

Head Containment, SKAN AG, Switzerland

Ildiko Ziegler

Ildiko Ziegler

Quality Assurance Manager, Vanessa Research

Stefano Butti

Stefano Butti

Sales Director, FPS

Ester Lovsin Barle

Ester Lovsin Barle

Head, Product Stewardship and Health, Takeda, Switzerland

Andreas Schreiner

Andreas Schreiner

Head of Validation, Novartis, Switzerland

Thomas Adam

Thomas Adam

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

Yossi Shapira

Yossi Shapira

Associate Director, MS&T S.M.E Teva Pharmaceuticals

Martin Kohan

Martin Kohan

Senior Occupational Toxicologist, SafeBridge

 Jacopo Buzzanca

Jacopo Buzzanca

Custom Synthesis Manager , Angelini Pharma, Italy

Martin Axon

Martin Axon

Senior Principal Occupational Hygienist , SafeBridge Europe

Jerome Detreille

Jerome Detreille

Senior Director, New Business Development, PCI Services, UK

SPONSORS

PARTNERS