Qepler | summits & conferences | Highly Potent APIs Summit, Berlin, 20 February 2019
Event Location:
Berlin, Germany
Venue:
RIU PLAZA Berlin Martin-Luther-Straße 1
Date:
20 February 2019 - 21 February 2019
Language:
English
Contact Person: Evgenia Makar
Contact Person: Evgenia Makar, Qepler s.r.o.
Contact Person: Denis Polikarpov
Contact Person: Denis Polikarpov, Qepler s.r.o.

Conference Overview

The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges. Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies.

The featured talks on:

  • EMA and GMP guidelines: novel requirements and considerations
  • Staying compliant with occupational HSE regulations and policies
  • Best practice containment strategies for highly potent APIs
  • Utilizing quality risk management practices to HPAPIs production
  • Handling and optimizing early process development
  • Understanding and developing a robust scale-up process
  • Handling highly potent compounds for ADC generation
  • Design and cleaning considerations for manufacturing facilities
  • Selecting the right CDMO partner for HPAPIs project
  • Successful technology transfer and outsourcing strategies

Meet our Speakers

Our Sponsors

Silver Sponsor
ILC Dover is a world leader in the innovative design and manufacturer of engineered products employing high-performance flexible materials to aerospace, medical and inflatables markets.
ILC Dover
Speaker Sponsor
Lonza is one of the world's leading suppliers to the Pharma&Biotech and Specialty Ingredient markets with products that enhance your overall quality of life.
Lonza AG

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