Join us at our 2016 International Education Conference in Orlando, at the Disney’s BoardWalk Inn! The Boardwalk is located within the Walt Disney World Resort and under 10 minutes from the Epcot Theme Park. In addition to the Education Conference, we are also hosting a Business Conference that will be held on the same days, at the same venue. Both offer a blind peer review option, and one registration fee will allow you to attend both co...

Overview: In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. Why should you Attend: Pr...

Overview: This session helps participants to learn how to effectively develop an aligned Lean Systems plan by transforming business strategies into agile, tactical actions. This method is used successfully by multiple types of organizations. Participants will be able apply samples relevant to their unique business environment. Managers will see how they can visualize, articulate and execute a plan to meet their LMS goals and objectives via Hos...

Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures a...

Course "US Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Break Overnight Clinical Trials IDE Other Export for trials Common problems in trial design and management Post marketing QSR CAPA Reporting Inspections Export for foreign markets Pop quiz Give quiz Discuss questions and answers Why should you attend? Have you had the e...

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and...

Join us December 16 as a panel of journalists-turned-public affairs officers reveals what they’ve learned in the often challenging and eye-opening transition from media to government. Our guests will include: John Poirier, formerly of Reuters and now with the U.S. Office of Financial Research Rich McIntyre, former managing editor of The Calvert Independent and since with various state and federal agencies Rob Margetta, one-time editor of...

Overview: The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated....

Overview: Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management. Too many times we try to manage our projects in a vacuum without awareness of how we impact the company overall, and how the company overall impacts our performance as project managers. Why should you Atten...

Overview: Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe. Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability stu...