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

Early Bird discounts:
Register early to save €300 for the Individual ticket, €400 per person for 2-3 Delegates, €600 per person for 4+ delegates from the same company until December 14th.

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

Networking

Harshal Shah

Cambridge Consultants

chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.