Easily Replace Advanced Field in the Product Defect Notice

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How to Replace Advanced Field in the Product Defect Notice

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good day and welcome to todays webinar improve product quality with advanced defect detection tools our presenter today is john stamos product marketing manager for the vision products business unit here at Cog max John has been at Cognex for over seven years with several years experience in our sales organization supporting both vision and Ivy products John has a bachelors degree in mechanical engineering from the University of Wisconsin and an MBA from the University of Chicago Booth School of Business welcome John thanks Karen and thank you everyone for taking the time out of your day to sit in on this webinar as you all know were here today today to talk about advanced defect detection so just to set the table well go over a quick agenda I want to give a high-level introduction to vision applications talk about the overview of markets for defect detection talk about some considerations when were approaching a defect detection application well talk through some of the tools th

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What is Article 61 of the CTR?

Article 61(5) of the Clinical Trial Regulation (CTR) (EU Regulation 536/2014) provides an exemption from the requirement to hold a manufacturers authorisation for the following processes, where they are carried out in a hospital, health centre or a clinic participating in the clinical trial; a) Re-labelling or re-

What happens after EMA approval?

CHMP scientific opinion After the evaluation, the CHMP issues a scientific opinion on whether the medicine may be authorised or not. EMA sends this opinion to the European Commission, which issues the marketing authorisation. EMA then publishes a summary of the committees opinion.

What is an unforeseen variation?

A variation is considered unforeseen when the proposed variation is not considered a minor variation of Type IB following the Commission Guideline, or has not been classified as a Type IB variation in an Article 5 recommendation.

What is suspension of marketing authorisation?

The suspension of a marketing authorisation is a precautionary measure, during which time a medicinal product is not available. The lifting of the suspension is conditional on the marketing authorisation holder resolving the issues identified by the Agency.

What is EMA quality defect?

The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines. Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorisation.

How to use the defective product report to notify a quality defect to European Medicines Agency?

Reporting a quality defect to EMA Notify EMA. Complete the defective product report template and submit to qdefect@ema.europa.eu: Provide investigation and health hazard assessment reports. Keep EMA informed.

What is referral procedure?

A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.

What is Article 61 3?

1. What are Article 61(3) notifications? Rev. Apr 2021. Article 61(3) refers to Directive 2001/83/EC in which a so-called 61(3) Notification is defined as a change to an aspect of the Labelling and/or Package Leaflet (PL) text not connected with the Summary of Product Characteristics (SmPC).

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Replace Advanced Field in the Product Defect Notice