When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceu...

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on speci...

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professi...

An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information...

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system valida...

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system vali...

Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflects the mor...

Course "The New Clinical Trials Regulation and Regulatory Affairs Aspects of Medicinal Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to...

Since July 2013, Regulation (EC) No 1223/2009 on Cosmetic Products of the EU has been fully implemented and represents a modern regulatory framework grounded on state of the art of cosmetic science and product technology. It is structured in regulatory modules, which include the safety assessment and the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), Responsible Person (RP), label information, cosmetovigilance, substanc...