MarketsandMarkets High Potent Medicines Conference

WHAT TO EXPECT

Process Development and scale up of HPAPI’s
Strategies for effective outsourcing partnership
Containment and Handling Strategies
Validation of cleaning procedures to avoid cross contamination
Regulatory Landscape
Hazard Assessment Classifications

Utilizing the best practices to ensure safe and efficient production of high 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

From pharmaceutical and Biopharmaceutical manufacturing:

Chief executives, VP’s, Directors, Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Toxicologists, Fellows, Investigators working in:

Research & Development
Manufacturing/Operations/Production
Maintenance
Engineering
Risk Assessments
Laboratory Services/Analytical
New Technologies
Process Development/Technical transfer

CONFERENCE AGENDA

Registration	08:00 - 08:50
Welcome note from MarketsandMarkets	08:50 - 08:55
Opening Remarks from the Chairperson	08:55 - 09:00
IMPLEMENTATION AND INTERPRETATION OF ADVANCED MANUFACTURING PRACTICES IN HPAPI
Keynote Presentation - Overcoming the Challenges Associated with Containment in HPAPI Manufacturing with Respirator Innovation	09:00 - 09:30
Challenges for Analysts Handling APIs in the Lab	09:30 - 10:00
Disinfection/Sterilization Process	10:00 - 10:30
Morning Refreshments and Poster Presentation \| One-to-One Networking Meetings	10:30 - 11:15
TBA	11:15 - 11:45
Pharmaceuticals and the environment: Impact, Stewardship, and Sustainability	11:45 - 12:15
TBA	12:15 - 12:45
RISK ASSESSMENTS & DECISION MAKING IN HPAPI
HPAPI Handling from Lab Bench to Pilot Plant within Chemical Development	12:45 - 13:15
Lunch and Poster Presentation \| One-to-One Networking Meetings	13:15 - 14:15
Process Improvement Through Change Initiatives and Cleaning/Equipment Validation	14:15 - 14:45
Panel Discussion: Revealing the Key Concerns of Each Perspective in High Potent Manufacturing and How that Directs their Decision Making	14:45 - 15:15
Revealing Novel PAT Assays for Biologic Detection at the Single Particle Scale to Avoid Cross Contamination	15:15 - 15:25
Gauging the Risk in the Cross-Contamination and Reprocessing of Medical and Pharma Devices to Increase Safety & Cost Effectiveness	15:25 - 15:40
Afternoon Refreshments and Poster Presentation \| One-to-One Networking Meetings	15:40 - 16:25
Essential Elements of HPAPI Projects with Respect to Patient Safety and Operator	16:25 - 16:55
Applying Our Outmost Understandings with HPAPI Controls to Improve Sustainability, Safety and Efficient Production	16:55 - 17:25
Closing Remarks from the Chairperson	17:25 - 17:30
Drinks Reception & Networking	17:30 - 17:30
End of Day 1	17:30 - 17:30

Registration	08:15 - 08:55
Welcome note from MarketsandMarkets	08:55 - 09:00
Opening remarks from the Chairman	09:00 - 09:10
DESIGNING ENGINEERING CONTROLS FOR HIGH POTENCY CONTAINMENT
Keynote Presentation- Trends and Outlook on Containment	09:10 - 09:40
Reserved Slot for Platinum Sponsor	09:40 - 10:10
How Should Risk, Hazard, and Uncertainty be Treated with Respect to Containment Controls?	10:10 - 10:25
Morning Refreshments and Poster Presentation \| One-to-One Networking Meetings	10:25 - 11:10
Reserved Slot for Gold Sponsor	11:10 - 11:40
Completing and Presenting a Convincing Quantitative Cost-Benefit Analysis and Discovering ALL the benefits of a containment investment in HPAPI	11:40 - 12:10
Reserved Slot for Silver Sponsor	12:10 - 12:40
A Hygienist’s Perspective in Broadening facilities to manage exposure/Common Pitfalls in Industrial Hygiene with Highly Potent APIs and the Means to Avoid them	12:40 - 13:10
Lunch and Poster Presentation \| One-to-One Networking Meetings	13:10 - 14:10
EFFECTIVE PLANT DESIGN - A VITAL COMPONENT OF MANUFACTURING
Exploring Advanced Technology for Next Generation Isolation Design	14:10 - 14:40
Uncovering How to Front-Load Facility Design so it goes Hand-in-Hand with Process Development	14:40 - 14:55
Reducing the environmental impact with optimized ventilation design	14:55 - 15:25
Afternoon Refreshments and Poster Presentation \| One-to-One Networking Meetings	15:25 - 16:05
Guidelines and Practices for the most cost-effective large-scale production of HPAPI products	16:05 - 16:35
Ventilation requirements for occupational hygiene exposure	16:35 - 17:05
Closing Remarks from the Chairman	17:05 - 17:05
End of Conference	17:05 - 17:05