Preparing the Marketing Authorization Application in the EU, with a focus on the product information

Date : 18th April 2018 to 19th April 2018

Place : Switzerland, zurich, switzerland

Website :https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901315SEMINAR?allconferencealerts-April-2018-SEO

Contact Person:Event Manager

Description:

In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed. Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easy-to-read format for patients. The SmPC provides the basis of information for healthcare professionals to use a medicine safely, effectively and in the most appropriate manner. It is also a legal document, agreed between the Authorities and the relevant pharmaceutical company. The format and content of the SmPC is laid down in EU/national legislation and regulatory guidance documents. Use of a medicine outside the conditions/ recommendations described in the SmPC falls under the responsibility of the healthcare professional. It is important to note that the SmPC is not intended to provide general advice on the treatment of particular medical conditions. On the other hand, specific aspects of the treatment related to use of the medicine, or its effects may be mentioned. Similarly, general advice on administration procedures is not included, but any advice specific to the medicine concerned will be included, if appropriate. The PL is drawn up in accordance with the SmPC and is subject to user-testing to ensure its ease of readability by patients/consumers. It plays an essential part in supporting the safe and effective use of a medicine by a patient. Consequently, it is important that a PL is provided each time a product is dispensed. Patients and care-givers should be encouraged to read the current version of the PL that accompanies their medicine(s) and to discuss any relevant concerns with a healthcare professional involved in their care Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901315SEMINAR?allconferencealerts-April-2018-SEO

Preparing the Marketing Authorization Application in the EU, with a focus on the product information will be held in zurich, switzerland,Switzerland on date 2018-04-19

---

Deadline for abstracts/proposals : 11th April 2018

Keynote Speakers : Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years

Conference Highlights :SmPC Package Leaflet Labelling Readability testing How to conduct presubmission meetings with the EMA and Rapporteurs Who will benefit: Regulatory Affairs personnel involved in Development of medicinal products

Venue :Zürich, Switzerland

Check the event website for more details.