ComplianceOnline, Online Event
2013-07-17
Why Should You Attend: International product registration has changed with the advent of new regulations across the globe. Requirements have changed, more documentation is needed in some cases. In Hague convention member states and non-Hague member states, companies can lose revenue simply by not having the right legalized documents. The process for approval or clearance of devices outside the USA varies from regulatory body to 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. Furthermore, recent scrutiny by US regulators and legal authorities is making it more uncertain for companies attempting to gain market access in foreign countries. This training will provide a guide to facilitate international registrations and reduce time to market by two months. Learning the relevant regulatory requirements and the appropriate document legalization path will speed up the pathway. Learning Objectives: Participants in this class will learn how to develop a plan, implement product registrations in a timely, efficient manner to help reduce their companies time to market. Areas Covered in the Webinar: - International regulation- what has changed (GCP)
- Role and responsibilities of US manufacturers
- Identifying the key players
- Where to find in-country distributors
- Sales forecasting – why is this necessary
- Types of documents need
- Medical Device vs Pharmaceuticals
- Best practices for document legalizations
- Apostille vs. Authentications
- How to get documents embassy legalized
- Pitfalls – What to look out for.
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