Key Sessions during the Highly Potent Active Pharmaceutical Conference Released

LONDON - Feb. 10, 2022 - PRLog -- SMi's 6th Annual Highly Potent APi Conference will also explore the ADC industry, legal aspects, environmental policy, and how to effectively establish a business case for containment – as well as taking a look to the future of HPAPI as new modalities continue to surface.

Taking place on 9^th – 10^th May 2022 in London, UK; the conference will focus on a robust scientific approach to handling HPAPI, from hazard identification and exposure limits to toxicological risk assessment.

Interested parties can register at: http://www.highlypotentapi.com/PR2PRLOG (http://www.highlypotentapi.com/PR21888PRLOG)  - register by 28th January 2022 to save £200.

SMi Group have released the key sessions that will be taking place over the two-day conference, see below for an excerpt:

OPENING ADDRESS - Key Elements of [Highly] Potent API Projects

• What is more Important?  Product Safety or Worker Safety?
• Higher Potency and Toxicity in Drug Pipelines
• Is SARS-CoV-2 and/or its Vaccines 'Potent'?
• Hazard, Risk and Control (and uncertainty)
• Potent Drug Facility Design

Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Ltd

SPOTLIGHT SESSION - Human Behaviours Leading to Safe & Successful Potent Product Manufacturing

• There have been progressive improvements in potent compound containment in Pharma within the last 20 years
• Great sharing of 'best practice', resulting in similar approaches across the sector
• A degree of 'health & safety anxiety' is observed when the API OELs go below 10 mcg/m3
• Expensive Containment infrastructure is only as useful as the human capability interacting with it
• Do we need to look at how we prepare workers handling extremely active, harmful chemical agents?
• This talk examines some of the key human factors that can influence a successful approach to handling potent compounds

Dr. Damien Boyd, Regional Industrial Hygiene (EMEA region), MSD

PANEL DISCUSSION - Highly Potent APIs in Pharma

• How can we ensure compliance with both Good Manufacturing Practice (GMP) and Environmental Health and Safety (EHS)?
• When should engineering controls be employed?
• How should Risk, Hazard, and Uncertainty be treated in this field?

Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Ltd
Olindo Lazzaro, Head, Global Occupational Safety, Novartis
Dr. Damien Boyd, Regional Industrial Hygiene (EMEA region), MSD
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

OPENING ADDRESS - Trends and Outlook on Containment

• Approaches for effective evaluation of cleaning validation and monitoring
• Fully automated Gloveless Robotic Aseptic Filling Line for high potent substances
• Clean to prevent Cross Contamination
• New ISPE DACH Containment Handbook introduction

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG

To find out more about the speaker-line up and conference agenda, please visit: http://www.highlypotentapi.com/PR2PRLOG (http://www.highlypotentapi.com/PR21888PRLOG) and register by 28^th February to save £200.