CQ5254 Pharmaceutical and Medical Device Labelling Summit
1. Optimise Your Labelling Strategies to
Ensure Accurate Product Information
and Successful Regulatory Compliance
27th
– 29th
October 2015
Maritim proArte Hotel Berlin, Germany
Stream 1: Pharmaceutical Labelling and
Company Core Data Sheets
Crucial regulatory feedback ensuring effective product
information and practical case studies on successfully
writing and managing company core data sheets
Stream 2: Labelling Compliance and UDI
Implementation for Medical Devices and
IVDs
Industry case studies and essential regulatory updates
for the future of medical device and IVD labelling and
practical implementation of the UDI system
Patricia Lefebvre
Sanofi
Sponsors:
Exhibitors:
The Pharmaceutical
and Medical Device
Labelling Summit
Klaus Menges
BfarM
Jackie Rae Elkin
Medtronic
Doris I. Stenver
PRAC
www.pmdlsummit.com
Steve Graham
Department of Health, UK
Igor Knezevic
Bayer Pharma AG,
Beth A. Lage
Baxter Healthcare
Guido Claes
Janssen
Géraldine Lissalde-Bonnet
GS1 Global Office
Peter Boege
Novo Nordisk
Laura Locati
Abbott Vascular
2. Pharmaceutical Labelling Medical Device and IVD Labelling
08.00 Conference Registration
08.50 Opening Remarks from the Chairperson
09.00 Pharmaceutical Labelling: Considering the Patient Regulatory and Legal Considerations of Labelling
Dual Discussion: The Life of a Diabetes Patient:
Improving the Readability of Pharmaceutical Drug
Labels
Carien Van der Karel van der Waarde
Graphic Design
Researcher
GLO, The Netherlands
Have
Diabetes Patient
The Netherlands
Dealing with the Medical Device Directive
Joachim Wilke
Director Regulatory Affairs Policy Europe
Medtronic, Germany
09.40 Translating Pharmacovigilance Requirements
into Effective Patient Information - Assessing the
Relationship Between PV and Labelling
Theo Raynor, Professor of Pharmacy Practice,
School of Healthcare
University of Leeds, UK
Industry Case Study – How to Control and Comply
with Country Specific Labelling Requirements.
Bianca Maria Gravenhorst Greve
Senior Regulatory Affairs Manager
Coloplast, Denmark
10.20 Effective Labelling for Medical Communication,
Patient Safety and Patient Adherence to the
Treatment
Ruxandra Rogosca
Drug Safety Unit Manager
Berlin-Chemie A.Menarini, Romania
Industry Feedback from Stryker on Destination
Labelling
Gil Lee
Program Manager of Global Labeling Team
Stryker Corporation, USA
11.00 Morning Coffee Exhibition Viewing
11.30 Ensuring Accuracy in Labelling and Preventing Errors
Willie Schnaubelt
Managing Director
Schlafender Hase GmbH, Germany
Panel Discussion: The Likelihood of
Global Labelling Harmonisation
This morning’s speakers will make up the
PANEL
facilitators of this session
12.10 Risk Management E-Labelling
Panel Discussion: Best Approaches and
Strategies to Make Pharmaceutical
Labelling More Patient Friendly
This morning’s speakers will make up the
IN
TERACTIV
E
facilitators of this session
E-Labelling at a Global level
Maurizio Suppo
Principal Consultant
Qarad, Italy
12.50 Lunch Exhibition Viewing
14.15 Closing the Gap Between Signal Detection and
Implementation in the Label
Boris Jankowski
Head of Solution Architecture Services
Sciformix, USA
Spotlight Session
S
POTLIGH
T
If you are interested in presenting on this topic
please contact Linda Cole:
Email linda.cole@informa.com,
Tel: +44 (0)20 7017 6631
14.55 Hear from the Regulators The Experience Exchange
An Interview with BfArM
Klaus Menges,
Director,
Federal Institute of Drugs and Medical Devices
(BfArM), Germany
Labelling Experience Exchange:
This interactive break-out session will allow attendees
to discuss particular challenges encountered with the
implementation of labelling strategies in an informal
environment. Attendees will gather in different groups
specific to their manufacturing products to guarantee
an industry-specific and accurate learning experience
through sharing of perspectives and challenges.
15.35 Afternoon Tea Exhibition Viewing
16.05 Spotlight Session If you are interested in presenting on
this topic please contact Linda Cole:
Email linda.cole@informa.com,
Tel: +44 (0)20 7017 6631
Implementing Radio Frequency Identification (RFID)
Industry Case Study - RFID and Labelling in Medical
Devices. A Timid Foray into a New Regulated Industry
Erik Paul
Manager Regulatory Affairs
Olympus Winter Ibe GmbH, Germany
16.45 Update From The Pharmacovigilance Risk
Assessment Committee (PRAC)
Doris I. Stenver
MPA Chief Medical Office
Pharmacovigilance Risk Assessment
Committee Delegate, Denmark
Risk Management
Labelling and Safety Risk Management According to
ISO14971
Peter Boege,
Design Controls and Risk Management Expert,
NovoNordisk, Denmark
1725 Utilising the QR Code
Dominique Westphal
Scientific Expert, EU-Co-operation
Paul-Ehrlich-Institute, Germany
17.25 Closing Remarks from the Chairperson
17.30 End of Day 1
18.05 Closing Remarks from the Chairperson End of Day 1
Day Tuesday 27th
October 20151
IN TERACTIV
E
S
POTLIGHT
3. Pharmaceutical Labelling Medical Device and IVD Labelling
08.50 Opening Remarks from the Chairperson
09.00 E-labelling, Software and Databases The New NHS eProcurement Strategy and its Effect on
Labelling
The Benefits Electronic Labelling Can Bring to
Industry
Igor Knezevic
Global Labeling Manager
Bayer Pharma AG, Germany
The NHS eProcurement Strategy : Why All Goods and
Services Supplied to the NHS Must Be Compliant with
GS1 and PEPPOL Standards
Steve Graham
eProcurement Lead, Commercial Directorate
Department of Health, UK
09.40 The Challenges and Opportunities in Transition
from XEVMPD to ISO IDMP
Guido Claes
Pharma RD Drug Development Information
Governance
Janssen, Belgium
Content Management Systems (CMS)
How to Maximise Content Management Systems (CMS)
Sebastian Gottel
Executive Vice President
SCHEMA Consulting GmbH, Germany
10.20 Linking Risk Management and Labelling
Patricia Lefebvre
Global Labeling - Global regulatory affairs
Sanofi, France
Industry Feedback on Implementing Content
Management Systems (CMS)
Katrin Thelen
Technical Writer
Bess, Germany
11.00 Morning Coffee Exhibition Viewing
11.30 Quick-fire Technology Showcase: Demonstration
of the Current Software on the Market to Assist
Data Management
If you are interested in presenting on this topic please
contact Linda Cole: Email linda.cole@informa.com,
Tel: +44 (0)20 7017 6631
Taking a Closer Look at the Label
Dual Discussion: Industry and Patient Perspective :
Improving the Readability of Medical Device Labels
Carien Van der Have
Diabetes Patient, The Netherlands
IN
TERACTIV
E
Jennifer Perkins
Technical Communications Manager
Thoratec, USA
12.10 Understanding and Dealing with Current Standards
Identifying and Marking Pharmaceutical Products
Using GS1 Standards
Géraldine Lissalde-Bonnet
Public Policy Senior Manager
GS1 Global Office, Belgium
12.50 Lunch Exhibition Viewing
14.15 Analysing the Importance of Tamper Proof Closures
Stephen Wilkins
Chief Executive
Child-Safe Packaging Group, United Kingdom
Clarifying the Requirements for Symbols Used in
Medical Device Labelling
Samantha Marshall
Regulatory Affairs Manager EMEA
Ansell Healthcare, UK
14.55 How to Manage Multiple Requests for Variation?
Dorka Mihajlova
Regulatory Specialists
Alkaloid AD Skopje, Macedonia
Spotlight Session
If you are interested in presenting on this topic
S
POTLIGH
T
please contact Linda Cole:
Email linda.cole@informa.com,
Tel: +44 (0)20 7017 6631
15.35 Afternoon Tea Speed Networking
16.05 Implementing Serialisation Guidance on Promotional Labelling
Serialisation: How? Why and When?
Maarten Van Baelen
Market Access Director,
European Generic and Biosimilar Medicines
Association (EGA)
Industry Feedback: Correctly Complying with Claims
in Promotional Material
Elena Varini
Intl Orthopedics Regulatory Manager
Orthofix Srl, Italy
16.45 Interactive “Simulating the Campfire” Session
Come together in an informal environment
to discuss the best approaches and
strategies to prepare for serialisation
What are the Repercussions of Not Correctly
Complying with Claims in Promotional Material
Shuna Mason
Partner
CMS Cameron McKenna LLP, UK
17.25 Closing Remarks from the Chairperson
17.30 End of Day 2
To register or for the latest information, please visit: www.pmdlsummit.com Tel: +44 (0)20 7017 7481 Email: registrations@informa-ls.com
Day Wednesday 28th
October 20152
IN
TERACTIV
E
4. Company Core Data Sheets UDI Implementation
08.50 Opening Remarks from the Chairperson
09.00 Implementing Company Core Data Sheets (CCDS) UDI in the US
How to Compile a Company Core Data Sheet (CCDS)
Barbara Lachmann
Labeling Consulting, Germany
Panel Discussion: Reflecting on the UDI Class 3 and 2
Deadlines in the US
Gil Lee
PANEL
Program Manager of Global Labeling Team
Stryker Corporation, USA
Jackie Rae Elkin Rob Bergman,
Global Process . W. L. Gore Associates, Inc.
Standard Product Packaging Labeling, USA
Medtronic, USA
Sharing Experience on Core Company Data Sheet and
Core Company Safety Information
Michel Mikhail
Expert in Global Regulatory Affairs, Member of the
US Pharmacopiea Committee of Experts,
Member of the Federal Governmental Institue
of Risk Assessment, Germany
Industry Case Studies
09.40 Industry Case Study: Best Practice and Strategies for
Implementing UDI
Jenny Gough
Process Development Manager/GS1 UDI Specialist
Operations-Value Chain Development and Efficiency
Molnlycke Health Care, UK
10.20 How to Organise and Implement Company Core Data
Sheets (CCDS)
Aaron Barzey
Senior Executive - Global Regulatory Affairs
Reckitt Benckiser, UK
Implementing the UDI System Using GS1 Standards
Géraldine Lissalde-Bonnet
Public Policy Senior Manager
GS1 Global Office, Belgium
11.00 Morning Coffee Exhibition Viewing
11.30 Industry Experience of Company Core Data Sheets (CCDS)
Anna Paul
Manager Global Regulatory Affairs
Grunenthal, Germany
UDI Industry-Specific Experience Exchange:
IN
TERACT
IVE
This interactive break-out session will allow attendees to
discuss particular challenges encountered with the
implementation of UDI strategies in an informal environment.
Attendees will gather in different groups specific to their
manufacturing products to guarantee an industry-specific
and accurate learning experience through sharing of perspectives
and challenges.
12.10 Pharmacovigilence UDI Globally
The Role of the Company Core Data Sheet (CCDS) as a
Pharmacovigilence Document
Cathrine Lang
Safety Surveillance Specialist NovoNordisk,
Denmark
UDI Implementation and Global Compatibility
Jackie Rae Elkin
Global Process Owner - Standard Product
Identification
Medtronic, USA
12.50 Lunch Exhibition Viewing
Webinar: Updating and Tracking the Company Core
Data Sheet (CCDS) WEBINAR
Beth A. Lage
Associate Director, Global Regulatory
Affairs,Regulatory Operations and
Compliance – Labeling
Baxter Healthcare Corporation, Inc., USA
UDI from Theory to Labelled Product
Virginie Siloret
Head of Quality, E.M.S.
Electro Medical Systems S.A., Switzerland
14.15
14.55 Brainstorm Session: Discovering the Best Approach
Strategy to Company Core Data Sheets (CCDS)
Facilitator:
Amer Alghabban
Quality Assurance Adviser, Polyphor AG, Former
Global Head, Director
QA Merck Serono, Switzerland
Case Study: Implementing UDI in a Small-Medium Sized
Global Company
Kaja Tengbjerg
Senior Regulatory Affairs Professional
Ambu, Denmark
15.35 Afternoon Tea Exhibition Viewing
Company Core Data Sheets (CCDS) Globally Post Market Surveillance
16.05 Webinar: Dealing with Company Core Data Sheet
(CCDS) When Working in Different Countries
Leander Fontaine
Managing Director
Pharmiceutics Labeling Services LLC, USA
UDI Implementation and Post Market Surveillance
Laura Locati
Regulatory Compliance and Quality System Director
EMEA
Abbott Vascular, Italy
16.45 Applying the CCDS to the Japanese Package Insert
Stewart Geary
Chief Medical Officer Senior Vice President
Eisai Co., Ltd., Japan
Industry Feedback on the Pilot of the Revised
Manufacturer Incident Reporting Form
Marta Carnielli
Manager, Safety Risk Management Surveillance
Ortho Clinical Diagnostics, France
17.25 Closing Remarks from the Chairperson
17.30 End of Day 3
Day Thursday 29th
October 20153
To register or for the latest information, please visit: www.pmdlsummit.com Tel: +44 (0)20 7017 7481 Email: registrations@informa-ls.com
W
EBINAR
5. To register or for the latest information, please visit: www.pmdlsummit.com Tel: +44 (0)20 7017 7481 Email: registrations@informa-ls.com
The Pharmaceutical and Medical
Device Labelling Summit
UDI Regulatory Experiences World Café
Register 18.15 • Start 18.30 • Finish 20.30 • An evening networking dinner will be provided
This interactive break-out session will allow attendees to discuss particular challenges encountered with the
implementation of UDI in an informal environment. Hear delegates share their anticipations and current state of play
in their respective regions. Benchmark best approaches and strategies to prepare for UDI implementation and get your
questions answered before joining another café table. World café tables will include:
Exploring Labelling Strategies Globally
Register 18.15 • Start 18.30 • Finish 20.30 • An evening networking dinner will be provided
This workshop provides a comprehensive understanding of labelling strategies and labelling regulation developments
outside of the EU. Gain the opportunity to analyse and asses the similarities and difference between EU and the rest of
the world. Optimise your success in entering these markets and hear success stories that could benefit your organisation.
Understanding The Falsified Medicines Directive
Register 18.15 • Start 18.30 • Finish 20.30 • An evening networking dinner will be provided
The Falsified Medicines Directive aims to target the increasing and ongoing threat to public health and safety of the
circulation of falsified medicines. The directive affects all levels of the supply chain and inflicts manufacturers with
numerous obligations. This workshop aims to clarify and strengthen your understanding of The Falsified Medicines
Directive to ensure correct compliance, reduce the risk of decreased sales as well as address the below points:
• How far along are we in the project and what lies ahead?
• How will the directive affect your workplace
• Strategies for implementation
• How will this affect countries outside the EU?
• Exploring rulings coming in or already in place worldwide
to stop the trade in falsified medicines
Workshop leader:
Amer Alghabban, Quality Assurance Adviser,
Polyphor AG, Former Global Head, Director QA
Merck Serono, Switzerland
Points to consider:
• Do you completely understand the proposed regulations?
• Are all stakeholders fully committed and aligned?
• Are you prepared for the vast amounts of collection and
aggregation of regulatory data?
• Do you understand the impact of UDI implementation on
your company’s operations?
Table 1: UK
Andrew Rutter, Regulatory Affairs Associate, Ortho
Clinical Diagnostics, UK
Table 2: North America
Jackie Rae Elkin, Global Process Owner - Standard
Product Identification, Medtronic, USA
Table 3: Rest of Europe
Géraldine Lissalde-Bonnet, Public Policy Senior
Manager, GS1 Global Office, Belgium
Each region specific session will address the following:
• The regulations in place for medical device labelling
• Recent developments in regulation on medical devices
• Case studies including best strategies and approaches to
dealing with multiple labelling requests
• Key challenges and how these are overcome
• Future developments for these regions
Session 1: US, Canada
Rob Bergman, W. L. Gore Associates, Inc.
Packaging Labeling, USA
Session 2: China
Maike Eva Kaae, Regulatory Affairs Specialist,
Radiometer, Denmark
Session 3: India ASEAN countries
Mohan Umale, Assoc. Manager Regulatory Affairs,
Stryker Global Technology Center, India
Session 4: Russia and CIS
Alexey Stepanov, Regulatory and Quality Assurance
Manager, Sorin Group, Russia
Free with
med dev
UDI day pass
Evening Seminar and Networking Dinner: Wednesday 28th
October 2015
Evening Seminar and Networking Dinner: Wednesday 28th
October 2015
Evening Seminar and Networking Dinner: Thursday 29th
October 2015
6. Pharmaceutical
Labelling and
Company Core
Data Sheets
Labelling
Compliance and
UDI Implementation
for Medical Devices
and IVDs
1 event: 2 streams
The Pharmaceutical and Medical
Device Labelling Summit
To register or for the latest information, please visit: www.pmdlsummit.com Tel: +44 (0)20 7017 7481 Email: registrations@informa-ls.com
The Pharmaceutical and Medical Device
Labelling Summit
Sponsorship Exhibition Opportunities
Sponsorship benefits include:
• Create a networking base at The Pharmaceutical and
Medical Device Labelling Summit. with an exhibition stand
in the main networking area, providing your team access to
the whole audience; an opportunity to meet new clients and
touch base with existing clients
• A speaking slot on the main programme giving your
company the chance to showcase its expertise
• Logo visibility with branding packages that ensure that your
company logo is seen by all of our attendees
• Networking drinks
Exclusive Opportunities:
• Lunch Sponsorship
Raise your corporate profile, branding and exclusivity by
hosting the delegate lunch which provides an opportunity
to informally address the audience and network in a relaxed
environment
Quick-fire Technology Showcase:
Demonstration of the Current Software on
the Market to Assist Data Management
We are looking for rising stars to showcase some of the latest
labelling technologies. Each service provider will take the
limelight for 15 minutes,providing a short and snappy summary
of some emerging technologies in labelling as part of this
interactive session.
Have you got the tech factor? If you are interested in presenting
on this topic please contact Linda Cole:
Email linda.cole@informa.com, Tel: +44 (0)20 7017 6631
• Chairing the event
Demonstrate your company’s status and lead the audience
through the day’s programme whilst sharing your expertise
by leading questions following individual presentations
Sponsored webinars
Take advantage of this new for 2015 opportunity to broaden
and strength your target audience by showcasing your latest
technologies and solutions to a global scale audience. This
unique opportunity allows for a flexible arrangement for both
vendors and customers.
,,
“
Sponsors and Exhibitors for 2015
Media Partners
Contact: Linda Cole Email linda.cole@informa.com
Telephone +44 (0)207 017 6631
27th
– 29th
October 2015
Maritim proArte Hotel Berlin, Germany
This was an excellent event. As a sponsor
and speaker, I met many new contacts and it offered
a perfect match for the companies we were looking to
meet.
Business Development, Schema
As a first time exhibitor at the Informa Labelling event,
I was very impressed with it. We made far more new
contacts than expected. This was a great platform for
the future and I highly recommend it.
mt-g medical translation GmbH Co. KG
7. To register or for the latest information, please visit: www.pmdlsummit.com Tel: +44 (0)20 7017 7481 Email: registrations@informa-ls.com
The Pharmaceutical and Medical Device
Labelling Summit
FACTS
FIGURES
Contact: Linda Cole Email linda.cole@informa.com • Tel +44 (0)207 017 6631
over 100different companies
attended in 2014
and
with 60%being Manager-level
above
20 top
100companies attended
in 2014
Make sure you
bring plenty of
business cards as
we are introducing
speed networking
2015...
Did you know....
2014 STATS
CEO level 12%
Director 12%
Head 8%
Manager 34%
Labelling
professionals34%
47%
15%
10%
5%
6%
4%
2%
2%
2%
2%
2%2% Regulatory
Director
Labelling
Manager
Medical Affairs
Project
Drug Safety
Pharmacology
Pharmacovigilance
Product information
Safety
Consultant
Past
Pharmaceutical
Labelling
Audience
Breakdown
44%
14%
9%
5%
6%
6%
3%
3%
2%
2%
2%
2%
2%2%
Regulatory
Labelling
Artwork
Manager
Quality
Marketing
Technical
UDI
Business Development
Consultant
Director
Documentation
Operations
Packaging
Past
Medical
Device Labelling
Audience
Breakdown
27th
– 29th
October 2015
Maritim proArte Hotel Berlin, Germany
Wheredidthe
delegatescome
fromin2014?
40%
2%
2%
2%
2%
4%
13%
8%
6%
6%
8%6%
Our audience
is interested to
meet solution
providers in the
following areas:
• Translation
• Readability
testing /User
testing
• Proofreading
• Structured
content
management
• Folded labels and
labels in general
• Change control
• Software
solutions
• Product
information
management
software
Take advantage of our extensive
database of labelling professionals:
+9000
Labelling
contacts +700Average unique pages
views per month in 2014
USA
Northern
Europe
Southern
Europe
