About this course
Informazioni sul Corso
Questo corso verrà tenuto parte in italiano e parte in inglese.
La Persona Qualificata ed il resto del personale tecnico devono essere informati e consapevoli della legislazione farmaceutica. I cambiamenti nella legislazione e nelle linee guida e la loro interpretazione, possono avere importanti implicazioni sia per i singoli che per le loro aziende.
Cosa imparerete
- La realtà quotidiana e l’interpretazione delle più recenti e nuove legislazioni EU
- Cambiamenti alle GMP Europee
- Un aggiornamento sulle ICH ed altre iniziative internazionali
- Cambiamenti nelle legislazioni USA e linee guida FDA
- Aggiornamenti italiani
About This course
This course will be run partly in Italian and partly in English
The Qualified Person and other technical personnel need to be informed and aware of pharmaceutical legislation. Changes in legislation and guidelines, and the interpretation of them, can have significant implications for the individual and their company.
What You Will Learn
- The reality and interpretation of recent and new EU legislation
- Changes to EU GMPs
- An update on ICH and other international initiatives
- USA changes to legislation and FDA guidance
- Italy updates
Course outline
Descrizione Generale del Corso
Recenti direttive e legislazioni EU
- La realtà quotidiana e l’interpretazione
- Responsabilità del QP
Cambiamenti alle GMP Europee: aggiornamenti e discussioni Sviluppi UK
Sviluppi internazionali
- Aggiornamento sui progressi delle linee guida dell’ICH, PIC/S, ecc.
Cambiamenti USA e FDA
Aggiornamento sui recenti cambiamenti alle legislazioni (o normative) farmaceutiche applicabili in Italia
Perché non utilizzare le vostre problematiche come fonte per la discussione?
Il seminario offre un’ottima opportunità per parlare con i docenti esperti e con gli altri partecipanti con ruoli simili ai vostri. I nostri seminari sono pianificati in modo da tenervi informati e permettervi di ottenere risposte ai vostri specifici quesiti attraverso dibattiti, sessioni di lavoro di gruppo e dibattiti pubblici.
Course Outline
Recent EU directives and regulations
- The reality and interpretation
- QP responsibilities
EU GMP changes: updates and discussions
UK developments
International developments
- Update on progress with guidance from ICH, PIC/S, etc
USA FDA changes
Update on recent changes to pharmaceutical legislation (or norms) applicable to Italy
Why Not Bring Your Problems For Discussion?
The seminar offers an ideal opportunity to speak to experienced tutors and to delegates who are in similar roles.
Our seminars are planned to inform you and also to enable you to gain answers to your specific queries via debate, group work sessions and a panel discussion.
Venue
Milan Marriott Hotel, Milan, Italy
Sede del corso
Milan Marriott Hotel, Milano, Italia
Il Milan Marriott Hotel è situato in una posizione comoda per raggiungere il centro della città con la possibilità di visitare centri commerciali, musei, luoghi storici ed altre attrazioni locali.
Sistemazione in Hotel
- Sarà vostra responsabilità prenotare le stanze di cui avete bisogno direttamente con l’Hotel per telefono (02-48521) oppure online su www.marriott.it
- Il conto con l’Hotel deve essere saldato alla partenza
- Qualunque tariffa addebitata dall’hotel per mancata presenza per qualunque motivazione, rimarrà a vostro carico, per tale motivo quindi per favore assicuratevi di conoscere la politica di cancellazione dell’hotel.
Venue
The Milan Marriott Hotel is conveniently located for reaching the city centre making it easy to visit shopping malls, museums, historical sights and other local attractions.
Hotel Accommodation
- It’s your responsibility to book any rooms you may require directly with the hotel either by phone (tel +39 02 48521) or online at www.marriott.it
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Milan Marriott Hotel
Via Washington, 66
Milan, 20146
Italy
Tel: +39-02-48521
Fax: +39-02-4818925
Tutors
Siamo convinti che il nostro team di esperti sia il migliore disponibile. Non solo hanno anni di esperienza nell’industria, ma si sono anche assunti l’impegno di guidare ed aiutare il personale delle industrie a migliorare e far crescere i propri standard. Crediamo che voi partecipiate ai corsi per conoscere le più recenti leggi regolatorie e per ottenere risposta alle vostre domande.
I nostri esperti per questo corso sono:
Claudia Savani
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
Claudia Savani
What you've said
“Really good content and pace. Good summary of all updates.”
Eleanor Power, Sanofi-Aventis Pharma, UK
“Great opportunity to keep up to date with the new regulations and to network with people facing the same future problems.”
Leen Van de Water, Pannoc, Belgium
“Short and sweet – great value for money!”
Jasbir Rattu, MSD Animal Health, UK
“As always a really valuable course to attend. Well presented and excellent documentation.”
Justin Barry, Midatech Biogune, Spain
“Always good to take a day out to re-evaluate impact on business and compliance with regards to continued change in legislation.”
Debbie Lloyd, BTG International, UK
“At a time of unprecedented change and more to come, this was an excellent course to highlight these changes to help check that I hadn’t missed anything and what this means to the industry. I am not alone!”
Carol Sandercock, Helena Biosciences Europe, UK
“Very useful to have all, or as many as possible, changes planned and implemented recently, pulled together in one place, especially to share with global organisation.”
Karen Deegan, Eli Lilly & Co, UK
“Good concise summary of upcoming legislation.”
Meriam Lindsay, Protherics UK
“A good concise update on current situation. Well delivered.”
Claire Trumper, Molecular Profiles, UK
“It was good to get an independent view from experts and this allowed me to clarify my interpretation of the changes into something realistic at work.”
Adam Haigh, Perrigo UK Ltd, UK
“An excellent summary of the current and future state of play in the regulatory arena globally. An essential course for myself as a QP.”
David Preston, Colgate Palmolive (UK) Ltd, UK
“Excellent value for money. Content and delivery very high standard.”
Mark Dignum, Contract QP Ltd, UK
“A great way to get a good bite sized appreciation of current and planned legislation changes accompanied by a high level of enthusiasm from the presenters!”
Robert Hughes, AstraZeneca Pharmaceuticals, UK
“Certainly important to keep up to date with legislation – will definitely bring this back to site/group as an ongoing requirement in future.”
Michael Kirk, Cara Partners Ltd, Republic of Ireland
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