4th Annual High Potent Medicines Conference; Led by 20+ Industry Experts (Rome, Italy - May 28-29, 2020)
DUBLIN, Jan. 24, 2020 /PRNewswire/ -- The "4th Annual High Potent Medicines Conference" conference has been added to ResearchAndMarkets.com's offering.
The 2-day event will share the latest industry trends, advancements and future growth in the highly potent medicines market where leading industry experts will discuss the strategies for both pharma and CMO's.
Expert keynote presentations, live case studies, and breakthrough panel sessions on solutions to the challenges with regards to cleaning and validation in API Manufacturing and procedures to avoid cross-contamination.
The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer.
One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations.
This conference would address the challenges in the continual evolution of industry standards, technologies, and regulations. Leading experts from the industry will discuss the strategies for both in-house manufacturing and outsourcing by presenting expert keynote presentations, live case studies and breakthrough panel discussions.
Learn from 20+ industry-leading speakers who will be sharing their presentations on challenges during the development of chemical processes of HPAPIs, Handling of highly potent products in a multi-product facility & Manufacturing Strategies for Highly Potent API's.
Why Attend?
- Utilizing the best practices to ensure the safe and efficient production of highly 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
Key Highlights
- Process Development and Scale Up of HPAPI's
- Risk Identification during Cleaning HPAPI's
- Cross-Contamination Prevention Case Studies
- Containment and Handling Strategies
- Regulatory Landscape
- Hazard Assessment Classifications
Agenda
DAY ONE
Registration
08:15 - 08:55
Welcome note
08:55 - 09:00
Opening Remarks from the Chairman
09:00 - 09:10
Keynote Presentation: Manufacturing Strategies for Highly Potent API's
09:10 - 09:45
PROCESS DEVELOPMENT AND SCALE UP OF HPAPI'S
Challenges during the development of chemical processes of HPAPIs - from lab to pilot plant scale
09:45 - 10:20
Morning Refreshments and Poster Presentation - One-to-One Networking Meetings
10:20 - 11:10
The development and manufacture of HPAPI drug products throughout the clinical phases
11:10 - 11:45
Solution Provider Presentation
11:45 - 12:20
ADCs requirements on high containment processing
12:20 - 12:55
Lunch and Poster Presentation - One-to-One Networking Meetings
12:55 - 13:55
Development and Manufacturing of Highly Potent APIs: from lab-scale to production scale
13:55 - 14:30
Making a successful outsourcing partnership
14:30 - 15:05
CONTAINMENT AND HANDLING STRATEGIES
Containment Equipment and Factors Affecting Containment Performance
15:05 - 15:40
Afternoon Refreshments and Poster Presentation - One-to-One Networking Meetings
15:40 - 16:30
Handling of highly potent products in a multi-product facility
16:30 - 17:05
Verifying the containment performance of pharmaceutical manufacturing and primary packaging equipment
17:05 - 17:40
Closing Remarks from the Chairman
17:40 - 17:45
Drinks Reception & Networking
17:45 - 19:00
DAY TWO
Registration
08:15 - 08:5
Welcome note
08:55 - 09:0
Opening Remarks from the Chairman
09:00 - 09:1
Keynote Presentation: Cleaning Validation in API Small Molecule
09:10 - 09:4
IDENTIFICATION OF RISKS DURING CLEANING HPAPI'S
Using banding approaches sensibly and appropriate use of cleaning limits
09:45 - 10:2
Morning Refreshments and Poster Presentation - One-to-One Networking Meetings
10:20 - 11:1
Solution Provider Presentation
11:10 - 11:4
Identification of high-risk products based on toxicological hazards for regulatory purposes
11:45 - 12:2
Prioritizing HPAPI's with respect to risks
12:20 - 13:0
Lunch and Poster Presentation - One-to-One Networking Meetings
13:05 - 14:0
OCCUPATIONAL TOXICOLOGY AND INDUSTRIAL HYGIENE
Applying occupational exposure limits on HPAPIs
14:05 - 14:4
Closing remarks from the Chairman
14:40 - 14:4
For more information about this conference visit https://www.researchandmarkets.com/r/pitkff
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