New Contractual Arrangements with Notified Bodies and Suppliers
1 Hour and 15 Minute Video | Elisabethann Wright, Hogan Lovells
The September 2013 recommendations require contractual authorization for notified bodies to make unannounced audits, and to perform product sampling and testing at manufacturing and supplier facilities. This simple requirement can have complex practical ramifications, and these new program areas may pose sensitive areas of negotiations for both manufacturers and notified bodies.
- Many existing contracts did not anticipate the new requirements. What steps can help minimize the impact on manufacturers and their suppliers while fulfilling the Commission’s requirements?
- Contractual agreement concerning payment for unannounced audits
- Duty to inform notified bodies of planned shutdowns in order to assist in planning unannounced audits. To what extent must the contract define shutdowns by product line and facility?
- Agreements to pay for samples and testing if done at a site other than the manufacturer
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Quality Assurance
- Legal Counsel
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Elisabethann Wright’s experience in the area of European Union law has included both periods in private practice and periods working with international institutions. She focuses on European Union (EU) law relating to life sciences, with particular emphasis on pharmaceutical law, medical devices, food law, and the environment. This includes assisting clients in classification of their products, establishment of a pathway to authorization and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals and data privacy obligations. She also challenges national authority and EU Institution decisions concerning classification and marketing of medicinal products and medical devices. Her practice is ranked number one in the PLC, Life Science Industry Super League as well as band 1 in Chambers Global 2012.
Elisabethann also advises on issues of EU administrative and constitutional law and public international law.
Prior to joining Hogan & Hartson, Elisabethann served as Senior Legal Officer and Hearing Officer at the EFTA Surveillance Authority.