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.
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.
08:30 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 An Ipsen Case Study in Potent Compound Handling.
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 PSD 3 Spray Dryer with results <1 ug/m3 using flexible containment.
14:40 Novel Antibody Drug Conjugate Manufacturing - Synthesis, Conjugation, and Coordination.
15:15 Cleaning Validation as one driver to prevent cross-contamination.
15:50 Afternoon coffee and networking break
16:20 Cleaning Validation for API: Reaching a Steady State.
Consultant, Formerly Novartis Senior QA and GMP Expert, Formerly Novartis, Basel, Switzerland
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 Understand, evaluate and mitigate Risks of occupational Exposures.
11:30 Chemical Exposure Assessment and Control; the Bayer HPAPI approach.
12:05 To Be Announced.
12:40 Business lunch
13:40 Analysis of containment testing.
14:15 Top ten audit findings from HPAPI facilities.
In order to have an effective potent compound safety program, auditing must be performed on a periodic basis. In this session, Dean Calhoun will share the top ten audit findings based decades of professional auditing experience throughout the world.
14:50 Challenges and Successes in Externalization of the ADC Supply Chain.
15:25 Afternoon coffee and networking break
15:55 Development & Manufacturing Considerations of High Potent Drug Products – a CDMO’s perspective.
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
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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.