International Product Registration: Documents Required
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Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500964?expDate=Sep9_2015_Internat |
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Category medical device manufacturing, medical device compliance, medical device registration, medical device regulation, international product registration
Deadline: September 08, 2015 | Date: September 09, 2015
Venue/Country: online Webinar, U.S.A
Updated: 2015-08-28 16:10:09 (GMT+9)
Call For Papers - CFP
International Product Registration: What are the documents required?Instructor: Marie DoratProduct ID: 500964DescriptionThe focus of this session is international product registration for IVDs & Medical Devices. Product registration requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced. In Hague convention member states and non-Hague member states, companies can lose revenue simply by not having the right legalized documents or specific government stamps and authentications.Why Should you AttendIndustry Executives and investors are complaining these days that their competitive edge is being jeopardized by the heightened regulatory scrutiny. For device companies based in the US, there is a growing trend in commercializing their products outside the country. In particular, many US-based companies are targeting new markets in the EU, China and, increasingly, India.The process for approval or clearance of devices varies from each regulatory body. In some cases, products achieve regulatory approval in an efficient and timely manner. In others, including the US FDA, companies may face a protracted and delayed approval process. Recent scrutiny by US regulators and legal authorities is making it more uncertain for companies attempting to gain market access in foreign countries.In an economy where getting the jump on your competitors is very important, this training will provide a guide to ease international registrations and reduce time to market. Learning the relevant regulatory requirements and the appropriate document legalization path will speed up the pathway.Objectives of the PresentationInternational regulation- Overview of country by country differencesRoles and responsibilities of US manufacturers & in-country distributorsIdentifying the key playersWorking with in-country distributorsSales forecasting ? Who needs to know?Types of documents neededMedical Device & IVDsBest practices for document legalizationsApostille vs. AuthenticationsHow to get documents embassy legalizedPitfalls ? What to look out forWho can BenefitRegulatory Affairs Specialist/ManagersProduct ManagersMarketing ProfessionalsAdministrative ProfessionalsFor Registration-http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500964?expDate=Sep9_2015_InternationalProductReg=Channel=ourglocalNote : Use coupon code 1371 and get 10% off on Registration
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