Name: 4th Annual MarketsandMarkets High Potent Medicines Virtual Conference ( Time Zone - CENTRAL EUROPEAN TIME (CET)
Start: 2020-09-14
End: 2020-09-15

20+

Speaker

10+

Networking Hours

4+

Sessions

150+

Attendees

EVENT OVERVIEW

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.

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

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

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

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 , Head Containment, SKAN AG, Switzerland	14:55 - 15:00
Keynote Presentation: Cleaning validation as one driver to prevent cross-contamination 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, Quality Assurance Manager, Vanessa Research	15:35 - 16:10
The safe house for your HPAPIs 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 , Sales Director, FPS	16:45 - 17:20
Manufacturing of Oncological Products by a CDMO 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, 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 , 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 , Head Containment, SKAN AG, Switzerland	14:55 - 15:00
Keynote Presentation: Regulatory updates in Health based exposure limits (HBELs) 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, Senior Occupational Toxicologist, SafeBridge	15:35 - 16:10
Assessing Containment Performance of Innovative Table Coating Equipment Martin Axon, Senior Principal Occupational Hygienist , SafeBridge Europe	16:10 - 16:45
High Potent Drug Product Facility and Operation, ‘Best Practice’: Jerome Detreille , Senior Director, New Business Development, PCI Services, UK	16:45 - 17:20
Containment HPAPI Handling Processing Strategy Best Practices Yossi Shapira , Associate Director, MS&T S.M.E Teva Pharmaceuticals	17:20 - 18:10
Closing remarks from the Chairman	18:10 - 18:15

Richard Denk

Head Containment, SKAN AG, Switzerland

Ildiko Ziegler

Quality Assurance Manager, Vanessa Research

Stefano Butti

Sales Director, FPS

Ester Lovsin Barle

Head, Product Stewardship and Health, Takeda, Switzerland

Andreas Schreiner

Head of Validation, Novartis, Switzerland

Thomas Adam

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

Yossi Shapira

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

Martin Kohan

Senior Occupational Toxicologist, SafeBridge

Jacopo Buzzanca

Custom Synthesis Manager , Angelini Pharma, Italy

Martin Axon

Senior Principal Occupational Hygienist , SafeBridge Europe

Jerome Detreille

Senior Director, New Business Development, PCI Services, UK

4th Annual MarketsandMarkets High Potent Medicines Virtual Conference ( Time Zone - CENTRAL EUROPEAN TIME (CET)

20+

10+

4+