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European Pharmaceutical Contractor

epc
Autumn 2019

   
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Good Clinical Practice
Expert Guidance on Inspection Processes

Dispelling the Fears of Inspection

NIHR’s Ross Downes guides you through the daunting process of GCP and MHRA inspections, from documentation and recruitment strategy to the importance of obtaining consent.
 
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EU MDR/IVDR in Clinical Research

Code of Conduct

Patricia Santos-Serrao at MasterControl assesses the current medical device and in vitro diagnostic legislation and how regulatory changes may impact clinical research.
 
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GCP Audit Preparation

Unfamiliar Grounds

Closed Loop Quality’s Iain Pulley imparts his knowledge on GCP audit processes and how to ensure the audit team is suitably prepared for effective review.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Connectivity, customization and sustainability driving packaging and drug delivery in 2020

Paris, 03 December 2019: Connectivity, customization and sustainability are driving pharmaceutical packaging and drug delivery innovation at Pharmapack Europe (#pharmapackeu), which opens in February 2020. The event is the leading exhibition dedicated to pharmaceutical packaging and drug delivery devices, with major industry players set to come together to discuss vital best practices, insights and strategies.
More info >>

White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
More info >>

Industry Events

2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
More info >>

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