HPAPI Day 1- Wednesday 1st November 2017

08:00 Registration opens

09:00

Opening remarks

Current and Future Trends in the Highly Potent Space

Marc Abromovitz
09:10

Control Banding-The Power of Hypnosis

  • The importance of a risk based decision making approach versus a hazard based approach
  • Why don't we use more data?
  • Are we overcompensating with occupational safety? How to avoid unnecessarily wasting resources
Reinhold Maeck
09:35

GMP meets EHS: legal aspects to consider regarding workers’ exposure and cross contamination

  • Cross contamination and EMA guideline
  • Legal aspects regarding OEL and PDE
  • Synergies and trends
Claudia Sehner
10:00

What to consider for a good quality PDE document?

  • PDE/ADE calculation basics
  • Toxicological prioritization of PDEs
  • Implementation of PDE program in big pharma
11:15

Considerations for risk assessments

  • Patient vs. worker risk assessment
  • Skin exposure
  • When mode of action sets the exposure limit unit
11:15

Project elements in rolling out an HPAPI project

  • It all starts with the hazard!
  • Proper, sensible risk assessment
  • Containment and control “hardware” and “software”
  • Dealing with engineers and equipment vendors
  • Did we get what we designed?
12:15

Containment and engineering round table 1

  • Examining real-life containment challenges and how they were overcome
  • A critical comparison of methods, equipment and facility design
12:15

Disruptive Containment Technology

  • History of old style containment systems
  • Why they are now out of date
  • New systems and methods of operation
  • Coming soon- new aseptic transfer technology
Michael Brimson, Sales Director, Ezi Dock Systems Ltd
13:15

Networking Lunch

14:45

Containment and engineering round table 2

  • Examining real-life containment challenges and how they were overcome
  • A critical comparison of methods, equipment and facility design
 
 
14:45

EHS Challenges of new ADCs

  • Banding system and Containment performance targets for ADCs mfg steps (conjugation, lyo/vial filling, packaging)
  • Strategy for IH method development for ADCs
  • Acceptable surface (wipe) limits for ADCs
 
14:45

Project elements in rolling out an HPAPI project

  • It all starts with the hazard!
  • Proper, sensible risk assessment
  • Containment and control “hardware” and “software”
  • Dealing with engineers and equipment vendors
  • Did we get what we designed?
15:45

Networking Break

Toxicological Limits and Risk Mitigation Strategies

Jorge González Borroto
16:45

Toxicological approach in PDE. Scientific analysis of preclinical toxicology and clinical data of API

  • Review of guidelines requirements for limit of exposure to API
  • Schedule of PDE procedures in pharma companies. How and what to consider
  • Data and Case study from internal experiences in PDE at Ferrer Internacional S.A (Medium Pharma company)
Michael Avraam
17:05

HPAPI contained transfer devices in a risk based era: A performance validation perspective

  • Containment performance and validation
  • How performance can improved but also be compromised
  • Assessing the particulate containment performance of pharmaceutical equipment – interpretation of the guidelines
Panel discussion
Justin Mason-Home
18:00

Chair's wrap up discussion

18:30

Poster Presentation and Networking Drinks

last published: 09/Oct/17 10:35 GMT