Pre-Conference Workshop Day

Pre-Conference Workshop Day: Tuesday, June 28

8:30 - 17:00

WORKSHOP A

Applying Traditional HPAPI Principles to Large Molecules

8:30 - 10:30  

In this workshop we will explore:

• Principals of Occupational Exposure Limits (OEL) and derivation of Occupation Exposure Bands (OEB)

• What similarities do OELs and OEBs share with Biosafety Levels (BSL) more commonly applied in large molecules?

• When is a biologically derived drug considered hazardous?

• Rising modalities in pharma pipelines and discussion on relative risks, including ADCs, monoclonal antibodies, peptides, enzymes, vaccines, oligonucleotide drugs

• Adjusting containment and engineering controls
for liquids

Workshop Leaders:

John Roosa hs

John Roosa
Associate Director / New Technology
Development and Industrial
Hygiene Lead
Merck & Co., Inc

Michelle Hernandez - Merck

Michelle Hernandez
Associate Director,
Occupational
Toxicology
Merck & Co., Inc

WORKSHOP B

Nitrosamine Impurities: Challenges in Pharmaceutical as an Example of a Rapidly Evolving Case

11:00 - 13:00  

Attendees will discuss:

• Nitrosamine impurity the constant evolving story

• Chemistry and classification (when compliance is the issue?)

• Industry challenges & continue research front

• Compendial response and tools to overcome Nitrosamines

• What’s next from public standard point of view

• Technical challenges of ‘confirmatory testing’

• Case studies of analytical approaches highlighting risk

• Collaboration opportunities

Workshop Leaders:

Naiffer Romero USP

Naiffer Romero
Scientific Affairs Sr. Manager
United State
Pharmacopeia

Amanda - USP

Amanda Guiraldelli,
Scientific Affairs Manager
United State
Pharmacopeia

WORKSHOP C

Understanding Human Error in EHS

14:00 - 17:00

Attendees will discuss:

• Do we understand why people err? Have you heard managers say “Why on earth did they do that???” or have you uttered “Not again!” in despair?

• Looking through the lens of the lessons learned in aviation, and other sectors, Rosie Russell will begin to unpack the psychology of work and give an insight as to how errors happen.

• This highly interactive workshop will use examples, case studies and group work to get delegates thinking about why errors occur and how to use this knowledge to manage the impact of error and increase reliability in the workplace

Workshop Leader:

Rosie Russel Meira GTx

Rosie Russell
Head of Environmental
Health & Safety
Meira GTx