The focus of this session is international product registration for IVDs & Medical Devices. Product registrations requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced.
Industry 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 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. 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 so 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.
Areas Covered in the Session :
- International regulation- Overview of country by country differences
- Role and responsibilities of US manufacturers & in-country distributors
- Identifying the key players
- Working with in-country distributors
- Sales forecasting – Who needs to know?
- Types of documents need
- Medical Device & IVDs
- Best practices for document legalizations
- Apostille vs. Authentications
- How to get documents embassy legalized
- Pitfalls – What to look out for.
Who Should Attend:
- Regulatory Affairs Specialists
- Regulatory Affairs Managers
- Product Managers
- Marketing Professionals
- Administrative Professionals
- Teams involved in new product registration
Course Director: MARIE DORAT
Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.
Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.
She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.
She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.