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Medicademy > Hot Topic Seminar - Latest Trends in Labelling / Product Information Management (PIM)
Hot Topic Seminar - Latest Trends in Labelling / Product Information Management (PIM)
Startdate:
25 March 2010
Duration:
1 Day(s)
Location:
Medicademy
Lersø Parkallé 101
2100 København Ø
Purpose:
New!!!
One day Hot Topic Seminars
 
We are at Medicademy Regulatory and Lif Education very proud to launch a new series of Regulatory Affairs Hot Topic seminars. These Hot Topic seminars will concentrate on and go into depth with hot topic subjects presented briefly in single presentations at the Medicademy modules.
 
The Hot Topic seminars will be open for everyone to participate and you do not have to have the two years of experience within the regulatory affairs area to participate.  
 
The first Hot Topic seminar is a unique opportunity to gain knowledge about a very HOT topic, which is very relevant and a “need to know” subject to many people. It will be presented by highly qualified lecturers. Register for:
 
  One day Medicademy/Lif Education
 
Hot Topic Seminar
 
Latest Trends in Labelling / Product Information Management (PIM)
 
March 25, 2010, 10.00 – 17.00
 
  At Lersoe Parkallé 101, 2100 Copenhagen, Denmark
 
 
 
Overview:
 
PIM is the new method of submitting product information in the EU Centralised Procedure (CP), presumably in future also for Mutual Recognition Procedure (MRP) and for National Procedure (NP) as well. With more than 20 different languages in the EU there is an increased burden on applicants and authorities to handle product information, especially during the time critical translation process. PIM has been introduced by the EMA to increase efficiency during exchange of product information and improve the quality and consistency of product information.
 
 This hot topic session is designed to give the participants the latest trends regarding labelling management, especially regarding upcoming requirements with EMAs emerging  Product Information Management System. The seminar speakers will share experience and perspectives e.g. Regulatory Agency, Industry and Vendor regarding the PIM submission development, change to business processes, impact on the translation process, challenges and opportunities, tools as well as the data exchange standard, XML and other templates used.
 
Content:
Content: 
1.       Introduction to Product Information Management (PIM) and XML 
 
2.       Agency perspectives - EMA and National Authority         
 
3.       Vendor presentation 
 
4.       Industry perspective
 
 
 
Programme:
 
1.      Welcome and intro to today – Trine Moulvad and Lene Krogh, Novo Nordisk
 
  •  
    • Setting the scene
    • What is XML, PIM and other acronyms
    • PIM/XML in the EU labelling world
2.      Agency perspective – Olivier Simoen, EMA London, UK
 
  •  
    • Status of PIM initiative
    • Letter of intent
    • Plans and challenges
3.      Industry perspective I  - Barbara Lachmann, MD, Global Regulatory Product Information, Merck KGaA, Germany
 
  •  
    • What strategy to choose (such as in-house or outsourcing and use of tools)?
    • Implementation issues, e.g. impact on workflow and processes
    • Why using Light Authoring Tool (LAT)?
    • Maintenance and conversion of product information
    • EFPIA PIM Implementation Networking Group activities
4.      Vendor presentation – Gilles Durot, i4i, Canada
 
  •  
    • Why choose complex content management solutions?
    • Discussion of scope and challenges
    • Customized solutions and consequences
    • PIM versus US FDA SPL format – differences and similarities
5.      Industry perspective II – Matt Hancock, Pfizer, UK 
 
  •  
    • What labelling strategy to choose, e.g. in-house or outsourcing?
    • Using more complex tools, e.g. Glemser instead of LAT
    • Considerations about handling and conversion of product information
    • EMEA PIM Migration Working Group activities
    • Implementation issues, e.g. impact on workflow and processes
6.      Panel discussion - All
 
Target:
Target Audience:
The seminar is open for anyone interested in this subject, but the target audience is professionals in:
 
·          HQ and Affiliate Regulatory Affairs staff
 
·          Document/content Management
 
·          Information Technology / e-publishing
 
·          Quality Control / Quality Assurance
 
  
Price:
DKK 3,700 ex VAT (approx. EUR 500). Course material and meals during the day included.
Cancellations must be in writing and must be sent to Medicademy.
 
Cancellations later than two weeks prior to the course, a cancellation fee of 50% of the course fee is charged.
 
Cancellations one day before or on the day of the course, a cancellation fee of 100% of the course fee is charged.
 
A booked seat can be transferred to another qualified participant free of charge.
 
In the event of circumstances beyond our control, Medicademy reserves the right to change the programme, lecturers, dates or venue, if necessary. If Medicademy cancels a course, the course fee will be fully reimbursed.
 
 
 
 
Registration deadline:
18 March 2010
Register:
DKK 3,700.00
VAT, 25% DKK 925.00
Incl. VAT DKK 4,625.00
Agenda
Day 1
Welcome and intro to today
a. Setting the scene

b. What is XML, PIM and other acronyms

c. PIM/XML in the EU labelling world
 
Lersø Parkallé 101    2100 København Ø    Tlf. 39 27 60 60    Fax. 39 27 60 70    uddannelse@dli.dk