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Interview with Pharma Microbiology Boston Event Chair Lynne Ensor on Coronavirus
SMi Reports: Lynne Ensor, Vice President, Technical, Parexel International discussed the latest development in the field, her thoughts on the developing regulatory environment and more.
By: SMi Group
SMi Group caught up with the conference chair Lynne Ensor, Vice President, Technical, Parexel International, to find out more about her expertise and role in the industry, what she's looking forward to at this year's Microbiology East Coast Conference, what vital topic she'll be addressing in her presentation, and much more.
In particular, Lynne provided a thorough overview of significant developments within the field from over the past year, including a discussion on the new Corona Virus.
Here is a snapshot of what was discussed:
The pharmaceutical microbiology market has matured greatly over recent years, what significant developments have you noticed in the last year within the field?
"With the most recent media headlines dominating our news feeds, the coronavirus outbreak is an excellent starting point. Since the question posed specifically asks about recent maturity of pharmaceutical microbiology, this outbreak highlights the utilization of recent pharmaceutical microbiology advances. Some of these advances allowed the organism to be identified quickly to determine if it was in fact a novel organism (as mentioned below), may assist in the determination of its origin, and allow for development of diagnostics for earlier detection. Areas where improvements are still needed and could be addressed with future advances in pharmaceutical microbiology have also been highlighted by COVID-19 and similar outbreaks, such as understanding 'super spreaders' of the virus."
What are your thoughts on the developing regulatory environment in sterile and non-sterile manufacturing and how is this currently impacting your role?
"Having recently departed from the FDA and having the opportunity to be involved in the development of countless regulations and guidance's, the publication of the Agency's guidance for microbiological consideration for non-sterile pharmaceutical manufacture is overdue and highly anticipated. The appropriate level of control and risk management within a manufacturing environment is critical."
The full interview can be downloaded from: www.microbiologyeastcoast.com/
Lynne will be presenting "Microbiological Quality Considerations in Non-Sterile Pharmaceutical Manufacture and Control of BCC" on day one of the conference.
Interested parties can register for the event at: www.microbiologyeastcoast.com/
For sponsorship enquiries contact Alia Malick on +44 (0)20 7827 6164 or amalick@smi-
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Pharmaceutical Microbiology East Coast 2020