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PHARMACEUTICAL INDUSTRY EVENTS CALENDAR

Outsourcing in clinical Trial Medical Devices Europe 2018

7-8 February 2018
Munich, Germany

Outsourcing in Clinical Trials: Medical Devices Europe has now reached its fifth birthday. This event is focused on Medical devices. At this event you will learn about the new regulations, which were released this may, regarding medical devices in more detail, from speakers who are the heads in their respective fields. 

Also, you will learn about the EUDAMED, pharma database system and GDPR here at OCT Medical Devices this year. Doing so will benefit you extremely!

Attending this event will boost your understanding with the new regulations, which will be implemented in 2020, and how to effectively use the EUDAMED and GDPR.

There are changes happening right now across Europe for medical device regulations regulatory authorities are asking for a lot more and a great variety of products. Also, there is a perception that the US regulatory process has become more difficult, and companies are acting by choosing to launch within Europe as it is perceived as a more predictable regulatory environment where they can work with CROs for a more local expert.

More than half of medical device companies are expected to hire additional employees to handle new business in the next year- teams are expanding indicating there is a huge delegate space to invite. Also, the lack of regulatory resources within organisations has prompted the move for smaller medical device companies to work in collaboration with CROs. 

Lastly, the global market for medical device outsourcing is predicated for growth over the next few years as brand owners increasingly transfer in-house manufacturing processes to third-party companies to streamline production costs and improve access to emerging markets. Service providers are meeting this demand by changing their models from functional to full service models instead.

 

 
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Industry Events

Pre-Filled Syringes & Injectable Drug Devices Europe

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SMi is proud to present their 11th annual European conference and exhibition, within the Pre-Filled Syringes series: Pre-Filled Syringes & Injectable Drug Devices Europe. The event will take place on the 16th-17th of January 2019, in London.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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News and Press Releases

BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.
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