Early Bird discounts:
Register early to save €500 for the Individual ticket, €600 per person for 2-3 Delegates, €700 per person for 4+ delegates from the same company until November 16.
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.
08:00 Registration and Welcome Coffee
08:50 Opening Address from the Chairman
09:00 GMP and Occupational Safety Requirements for highly potent aseptic processing.
09:35 Speed Networking
10:15 Practical Delivery of HPAPI Projects.
10:50 Morning coffee and networking break
11:20 Case Study #3 RESERVED
11:55 Risk-based handling of highly potent APIs: cross-contamination and transportation parameters.
12:30 The Importance of Involving Your People
Risk assessment is a statutory process that has many benefits. Research shows that involving employees in job based risk assessment has many benefits for any business, not least leading to improved organisational and employee knowledge. In todays brain based economy can organisations afford not to develop the knowledge of their employees?
This session highlights the unseen benefits of listening and involving your employees.
13:05 Business lunch
14:05 Case Study #6 RESERVED
14:05 PSD 3 Spray Dryer with results `<`1 ug/m3 using flexible containment.
15:15 Novel Antibody Drug Conjugate Manufacturing - Synthesis, Conjugation, and Coordination
15:50 Afternoon coffee and networking break
16:20 Cleaning Validation for API: Reaching a Steady State.
16:55 Analytical Approach for Implementation of Visual Inspection.
Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass visual inspection before swab sampling for analysis can be performed. However, since a significant number of low risk compounds are visible well below established safety levels, it is possible to justify equipment as “visually clean” without performing swabbing analysis. Internal studies performed at BMS showed that over 90% of participants could identify residual product at a level of ~2 ppm without preliminary training. The implementation of a robust visual inspection qualification program and clear “Visually Clean” inspection parameters can enable visual inspection to be used to qualify equipment in lieu of swab analysis for low risk products.
17:30 Roundtable Discussions
18:00 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:00 Registration and Welcome Coffee
08:40 Opening Address from the Chairman
08:50 WORKSHOP - How to identify high potency and high toxicity and what to do with it
09:50 Exposure Monitoring at the workplace - challenges due to workplaces and the new EN689
10:25 Morning coffee and networking break
10:55 OEB and OEL establishment and management in production operations with a highly potent compound
11:30 Case Study #4 RESERVED
12:05 Chemical Exposure Assessment and Control; the Bayer HPAPI approach.
12:40 Business lunch
13:40 Case Study #6 RESERVED
14:15 Analysis of containment testing.
14:50 Top ten audit findings from HPAPI facilities.
15:25 Afternoon coffee and networking break
15:55 Challenges and Successes in Externalization of the ADC Supply Chain.
16:20 OUTSOURCING 4.0: innovative Pharma creates the CMO net.
16:55 Roundtable Discussions
17:25 Chairman’s closing remarks and end of summit
To register to the summit as Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at firstname.lastname@example.org
Please fill in the details below to request your copy of the latest summit agenda and event details.
Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
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.