NSF COURSE – Updates on International Pharmaceutical Legislation – 2019 Edition

Date: 05/11/2019 - 06/11/2019
Venue: Hotel Michelangelo, Milano
Download Agenda


Following up the success of the 2018 Edition, we will organize again in Milano the most important training and informative event about the latest trends in international regulatory sector.

The Qualified Person (QP) and other technical staff need to be informed and updated on pharmaceutical legislation, Changes in legislation and guindelies and their correcy interpretation can have a significant impact both for user and for his company.

What you’ll learn in this one day course
• Structure and interpretation of the new European legislation
• Changes in European GMPs
• Updates on ICH and other international initiatives
• Changes in USA legislation and in FDS regulations
• Updates on legislation in Italy

Programma del corso
• Latest European directives and regulations

– Regulations 536/2014 for Clinical Trials
– Current updates on GMP
– Safety Features 161/2016 implementation
– Regulations 2017/745 for Medical Devices
– Shortage in Critical Medicines

• EMA: reinterpretation of health based exposure limits
• Other Changes in EU GMP and Annexes
• Potential impacts of Brexit on EU pharmaceutical industry
• Data Integrity: EMA, MHRA, WHO guidelines
• Updates on progresses in ICH guidelines
• Variations in FDA regulations
• Updates on recent changes in Italian regulations

Why not sharing your problems to discuss them together?
The course is an opportunity to share experiences with solidly skilled tutors and with collegues who have roles similar  to yours. Our courses are planned to keep you informed and to give you answers through discussions and work groups.

Seminar Tutors
We believe that our team of experts is the best available. Not only they have years of experience in the pharmaceutical industry, but they also have committed to lead and support people in improving and raising the standards. We believe that you attend courses to learn the latest news in regulatory affairs.

Hotel Michelangelo – Piazza Luigi di Savoia, 6 – Milano
Metropolitana Linea 2 – 3 (fermata Stazione Centrale)

Registration Fee
● € 665,00 for AFI associates
● € 600,00 for the second AFI associate
● € 770,00 for AFI non associates
● € 640,00 for the second AFI non associate
(only a discounted fee sor site)
Note: Request from companies based in EU will not be subject to VAT, PROVIDED THAT Vat Number is stated at the moment of registration, otherwise it will be applied.

Registration fee include:
● one lunch
● two coffee breaks

Registration and Payment
Registration must be finalised by filling the registration form and sending it via fax by 29 october  to New Aurameeting; after receiving confirmation from New Aurameeting, Registration fee will have to be paid by band transfer using the following coordinates:
● NSF Health Sciences Ltd
IBAN: GB61NWBK60720884008636

PAYMENT MUST BE MADE STRICTLY BY 29 OCTOBER. New Aurameeting will send the confirmation by mail. Registration will be accepted until seats are available.

For further info, please contact the Organizing Secretariat:
New Aurameeting Srl
Via Rocca d’Anfo, 7 – 20161 Milano
Tel. 0039 02 6620 3390
eventi@newaurameeting.it – www.newaurameeting.it


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