PDA Europe Webinar - The Chemistry of Nitrosamines – Implications for Risk Assessment
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Chemistry and Risk Assessment of N-nitrosamines with Focus on Drug Product and Elastomeric Primary Packaging Components
Dear Colleagues,
Since their discovery in June 2018, nitrosamines have received a lot of attention amongst global pharmaceutical industry. Recent decisions from regulatory bodies involve the development of a risk assessment and a possible reduction and control of nitrosamines in the final drug product by the marketing authorization holder. Now, we have all been allowed extra time for the preparation of the risk assessment for the EDQM. But still, this topic is quite complex and there are several open questions.
In this webinar, we want to address some of the open questions, for example, how can we account for the specific chemistry of nitrosamines in the risk assessment and how play elastomeric components a role here?
This and more will be covered both from the perspectives of a pharmaceutical company as well as a rubber component supplier.
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Member Price
€199GovernmentMember Only
€199
Health AuthorityMember Only
€199
Early Career ProfessionalMember Only
€199
StudentMember Only
€199
AcademicMember Only
€199
Non-Member
€199
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
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Introduction to Nitrosamines: |
Bettine Boltres, WEST |
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A Pharmaceutical Perspective:
|
Steve Baertschi, Consultant |
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An Elastomeric Primary Packaging Perspective:
|
Bettine Boltres, WEST |
| How to Utilize Risk Assessment based on Components Results | Steve Baertschi, Consultant |
| Interactive Live Q&A and Discussion |
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