To Register: Please quote CQ5212Please Tel: +44 (0) 20 7017 7481 Web: www.informa-ls.com/pharmalabellingFax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com

Our expert speaker panel includes:• Doris Stenver,

Chief Medical Officer, Danish Medicines Agency, Denmark

• Dominique Westphal, EU Co-operation, Paul-Ehrlich Institute,Germany

• Rozalina Kulaksasova, Head of MedicinalInformation Division, Medicines Use ControlDepartment, Bulgarian Drug Agency, Bulgaria

Industry Speakers: • Deborah Bebbington, VP, Head Global

Labelling, Global Regulatory Affairs, Bayer, UK• Anne Lenihan, Global Regulatory Lead, Pfizer,

UK• Lesley Wise, Senior Director, Global PV Risk

Management, Takeda PharmaceuticalsInternational, UK

• Melanie Eatough, Labelling Director, GlobalRegulatory Affairs, Shire Pharmaceuticals, UK

• Patricia Lefebvre, Head, Internal MedicineTherapeutic Domain, Global Labelling, Sanofi,France

• Gemma Jiménez, Head of Corporate DrugSafety EU Qualified Person forPharmacovigilance, Almirall, Spain

• Su-Yueh Lin, Director, Regulatory Labeling,Regeneron Pharmaceuticals Inc, USA

• Barbara Lachmann, Senior Labelling Advisor,Merck KGaA, Germany

• Laura Larrú, Senior Medical Safety Specialist,Alcon, Spain

• Megann Looker, Senior Manager, RegulatoryLabelling, Celgene, UK

• Horst Kastrup, Executive Vice President,Vitapharma Generics, Germany

• Rob Begnett, Global Clinical, Medical andVigilance, Senior Core Safety Writer, ReckittBenckiser, UK

• Karel van der Waarde, PharmaceuticalsConsultant and Graphic Design Researcher

• Hoss Dowlat, Vice President, PharmaBioConsulting, Germany

Sponsor: Exhibitors:

What makes this event unbeatable?3 Real life industry strategies on implementing the pharmacovigilance legislation3 Essential overview of the new regulatory requirements for labelling from 3 keyregulators

3 Practical advice on how to successfully implement the CCSI and CCDS process forlabelling

3 Industry perspective on the EC review of the SmPC and PIL for readability3 9+ hours of networking with senior industry labelling experts

3 Real life industry case study on successfully introducing the QrD template 9.0into national labelling and examining the pitfalls of implementation

3 Assessing the common challenges of successfully implementing a riskmanagement plan for labelling

3 Examining the impact of the pharmacovigilance legislation on the company'ssafety labelling process

3 Gain essential feedback on how PSURs should work in daily practice andexamine their impact on labelling

9 – 10 October 2013 | Millennium Gloucester Hotel London Kensington | London | UK

Pre-conference focus day X: Tuesday 8 October 2013

Essential points to consider for self-auditing of the safety labelling processLed by: Barbara Lachmann, Senior Labelling Advisor, Merck KGaA, Germany

Evening Seminar S: Wednesday 9 October 2013

Practically complying with US labelling requirements Understanding the requirements for labelling in the US Led by: Melanie Eatough, Labelling Director, Global Regulatory Affairs, Shire Pharmaceuticals, UKPatricia Lefebvre, Head, Internal Medicine Therapeutic Domain, Global Labelling, Sanofi, FranceSu-Yueh Lin, Director, Regulatory Labeling, Regeneron Pharmaceuticals Inc, USA

Don’t miss these essential learning and networking opportunities: Includesnetworkingdinner

Includesnetworkingdinner

3RegulatorySpeakers

Practically complying with the new pharmacovigilance legislation andexamining strategies for submitting and managing labelling information

www.informa-ls.com/pharmalabellingPackaging and labelling

issues are the primary cause

of 33% of medication

errorsPharmaceuticalLabelling

New for 2013

To Register Please Tel: +44 (0) 20 7017 7481 Web: www.informa-ls.com/pharmalabellingFax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please quote CQ5212

Conference Day 1: Wednesday 9 October 2013

Pre-Conference Workshop: Tuesday 8 October 2013Essential points to consider for self-auditing of the safety labeling process

Led by: Barbara Lachmann, Senior Labelling Advisor, Merck KGaA, GermanyThis is a pre-conference workshop starting at 14.00. The workshop will finish no later than 20:30. Workshop documents, refreshments and an evening meal will be provided

This focused workshop will provide attendees with a thorough understanding ofthe necessary internal considerations to be taken for self-auditing of the safetylabelling processTopics to be addressed include:1. Examining regulatory expectations surrounding the safety labelling

process: what do the EU authorities want to see?2. Actively managing the safety labelling process: which steps need to be

determined?3. Examining options to document the performance of the safety labelling

process: which kind of systems may be needed?4. Understanding the impact of non-compliance with authority

expectations: how can improvements via corrective action plans bedocumented?

About your workshop leader:Barbara Lachmann joined Merck KGaA in February 2002 to create a Global Labellingfunction dedicated solely to labelling topics as a centre of expertise within GlobalRegulatory Affairs. The main objective of this Global Labelling function is to ensureconsistent product information documents world-wide which adequately reflect thescientific information required for safe and effective use of the company's products overthe complete life-cycle. Following successful implementation of the new function, BarbaraLachmann now serves the Merck Serono division of the company as the Senior Advisor inthe Center of Excellence Product Information providing guidance on the overall labelingstrategy of the company as well as on individual product labelling strategies. Barbarasparticular interest and record of experience are focused on the issue of globalharmonization of labelling and the implementation of corporate labelling strategies intolocal product information texts under consideration of various local or regional exigencies(e.g. in the European Union, the USA, Canada and Japan).

08.15 Conference registration09.00 Opening remarks from the chair

Lesley Wise, Senior Director, Global PV Risk Management, TakedaPharmaceuticals International, UK

Interpreting the pharmacovigilance legislation

09.10 Interpreting the legislation for labelling for the newpharmacovigilance guidelines: what does this mean in practicefor your organisation? • Strategies for practically complying with the legislation• Examining and implementing recommendations from PRAC• Clarifying changes surrounding the quality of product informationand standards for quality

Deborah Bebbington, VP, Head Global Labelling, GlobalRegulatory Affairs, Bayer, UK

09.45 Examining the impact of the pharmacovigilance legislation:considerations for well-established and generic products• Specific challenges for well-established products• Clarifying the situation if the originator product is no longer onthe market: what are the implications for labelling?

• Implementing EMA safety information as a generics company• Clarifying requirements for translation and product nameHorst Kastrup, Executive Vice President, Vitapharma Generics,Germany

10.20 Regulatory authority: Providing clarification on the blacktriangle and the list of products for intensive monitoring • What is the timeline for the list of products that will be underintensive monitoring?

• Providing clarification on the final list of products that requireadditional monitoring

• Understanding the logistical impact of the black triangle: updatinglabels, symbols and text

Dominique Westphal, EU Co-operation, Paul-Ehrlich Institute,Germany

10.55 Networking and morning coffee11.30 Internal auditing of the safety labelling process

• Examining the impact of the pharmacovigilance legislation on thecompany’s safety labelling process

• Understanding EU regulatory expectations surrounding the safetylabelling process

• Actively managing the performance of the safety labelling process• Documenting the performance of the safety labelling process• Understanding potential consequences of self-auditing findings Barbara Lachmann, Senior Labelling Advisor, Merck KGaA,Germany

Risk management

12.05 Successfully implementing a risk management plan andrelationship to labelling• Clarifying regulatory expectations for risk management plans• Examining the relationship between the risk management planand the content of the SMPC

• Challenges with summarising the risk management plan in laylanguage

Lesley Wise, Senior Director, Global PV Risk Management, TakedaPharmaceuticals International, UK

12.40 Networking lunch

The QrD template version 9.0

13.50 Clarifying requirements for the new EMA QrD template (version 9)• An introduction to annex 5: providing clarification on how adversedrug reactions (ADRs) should be recorded

• Understanding what training templates are available to industry • Hyperlink: understanding what the manufacturer or countryrepresentative should do

• Examining how the new template will improve readability• An update on implementation gone so far throughout the EURozalina Kulaksazova, Head of Medicinal Information Division,Medicines Use Control Department, Bulgarian Drug Agency,Bulgaria

14.25 Case study: Practically implementing the QrD template• Successfully ensuring compliance with regulatory requirements• Examining what should be included in the risk management plan• Successfully introducing the QrD template into national labelling • Clarifying the requirements surrounding reporting adverse drugreactions

• What were the pitfalls of implementation? • Recommendations for improvements to the QrD template Megann Looker, Senior Manager, Regulatory Labelling, Celgene, UK

15.00 Spotlight sessionRaise your corporate profile by sponsoring or exhibiting at InformaLife Sciences’ Pharmaceutical Labelling. For details on speaking inthis session or other sponsorship opportunities at this conference pleasecontact Linda Cole, Tel: +44 (0) 20 7017 6631, Email: linda.cole@informa.com

15.35 Networking and afternoon tea

Company Core Data Sheets

16.05 Exploring the impact of the pharmacovigilance legislation on thecompany core data sheet• Examining the key regulatory expectations for harmonised productinformation from the authorities

• Examining the link of the CCDS to Risk Management• Effectively handling requirements from global authoritiesRob Begnett, Global Clinical, Medical and Vigilance, Senior CoreSafety Writer, Reckitt Benckiser, UK

16.40 Effectively implementing the CCSI/CCDS process for labelling• History of the CCSI concept: from the first references until the newEU Pharmacovigilance Legislation

• CCSI content and related documents• Effectively updating the labels vs. CCSI: practical aspects &recommendations

Laura Larrú, Senior Medical Safety Specialist,Alcon, Spain17.15 End of day one

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“The event was interesting with opportunity for interaction between the speakers and audience” Global Regulatory Affairs - Labelling, CNS and Pain, Janssen R&D

“This was an interesting informative and well organised event. Thespeakers were knowledgeable and engaging and the venue was very good”

Senior Analyst, Regulatory Policy & Intelligence, AbbVie Ltd.“Very informative conference. Good update on current thinking andupcoming changes in the labelling area”

Senior Regulatory Affairs Manager, NDA Regulatory Science

To Register Please Tel: +44 (0) 20 7017 7481 Web: www.informa-ls.com/pharmalabellingFax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please quote CQ5212

Evening Seminar: Wednesday 9 October 2013Complying with US labelling requirements

Led by: Melanie Eatough, Labelling Director, Global Regulatory Affairs, Shire Pharmaceuticals, UKSu-Yueh-Lin, Director, Regulatory Labelling, Regeneron Pharmaceuticals Inc, USA

Patricia Lefebvre, Head, Internal Medicine Therapeutic Domain, Global Labelling, Sanofi, FranceRegistration is at 18:00 for a 18:15 start. The seminar will finish no later than 20:30 and will be followed by an evening meal.

A brief description of PLR requirements: content and formatContentExamining the main differences in content between USPI and EU SmPCwith a focus on the following sections • Adverse reactions• Clinical studies• Paediatrics• PharmacogenomicsFormatClarifying the main differences in format between USPI and EU SmPC:USPI format requirements versus EU QRD requirements• Understanding how these differences can be managed globally

• Providing a comparison between US medication guide and EU PILPatricia Lefebvre, Head, Internal Medicine Therapeutic Domain, GlobalLabelling, Sanofi, France Understanding the requirements for labelling in the US• Clarifying the main differences between the US and the EU• Understanding the US prescribing information and SmPCMelanie Eatough, Labelling Director, Global Regulatory Affairs, ShirePharmaceuticals, UKFurther discussion on US labeling regulationSu-Yueh Lin, Director, Regulatory Labeling, Regeneron PharmaceuticalsInc, USA

Conference Day 2: Thursday 10 October 2013

“Excellent opportunity to exchange information and experiences” Biomedical Research Assistant, Bosnalijek dd

09.00 Opening remarks from the ChairPatricia Lefebvre, Head, Internal Medicine Therapeutic Domain,Global Labelling, Sanofi, France

Readability, Patient Information Leaflet and SmPC

09.10 The EC review of the SmPC and PIL for readability: what willthe impact be for industry?• Examining the short comings of prescribing information: why wasthe report commissioned?

• Current status• Altering the PIL structure to have 1) key information 2) further information on potential ‘benefits’ of the medicine 3) an electronic PIL

• Key recommendations for improving the PIL/ SmPC andexamining the implications for industry

Anne Lenihan, Regulatory Director, Pfizer, UK09.45 Examining readability and comprehension of the SmPC

• What are healthcare professionals looking for from the SmPC?• What are the pros and cons of having a core SmPC?Dominique Westphal, EU Co-operation, Paul-Ehrlich Institute,Germany

10.20 Patient Information Leaflets: What should they look like in anideal world?• Ensuring PILs are as patient friendly as possible• Effectively conveying crucial & complex informationKarel van der Waarde, Pharmaceuticals Consultant and GraphicDesign Researcher, Belgium

10.55 Networking and morning coffee 11.30 Bridging studies and readability testing

• Interpreting the EMA’s standards for readability• Understanding the most appropriate time to do readability testingfor the PIL: Original dossier vs. later stage

• To what extent is the patient input useful and what are the limitsof user testing assessment?

• Clarifying regulatory requirements for bridging and understandingto what extent you can bridge

Hoss Dowlat, Vice President, PharmaBio Consulting, Germany12.05 Spotlight session

Raise your corporate profile by sponsoring or exhibiting at InformaLife Sciences’ Pharmaceutical Labelling. For details on speaking inthis session or other sponsorship opportunities at this conferenceplease contact Linda Cole, Tel: +44 (0) 20 7017 6631, Email: linda.cole@informa.com

12.35 Networking lunch

Pharmacovigilance13.45 Understanding how PSURs (Periodic Safety Update Reports)

should work in daily practice and their impact on labelling• What do the authorities want to see?• What will replace the CSP?• Reference for safety and a reference for efficacy• Making changes to the SmPC data within the reference period Gemma Jiménez, Head of Corporate Drug Safety EU QualifiedPerson for Pharmacovigilance, Almirall, Spain

14.20 Crucial update on the pharmacovigilance legislation and itsimpact on labelling: where are we now?• Providing clarification on the key changes for labelling under thepharmacovigilance legislation

• Effectively implementing the pharmacovigilance legislation froma global perspective

• Which of the pharmacovigilance modules will affect labelling?Doris Stenver, Chief Medical Officer, Danish Medicines Agency,Denmark

14.55 Networking and afternoon teaArtwork

15.25 Case study: Implementing an efficient system to improve QMS inan artwork studio• Examining the benefits of a QMS in a GMP artwork studio • A GMP compliant artwork process • Standards • How asset management and workflow technologies improveeffectiveness

Suzanne Ivory, PS9000, IrelandTranslation

16.00 Roundtable discussion: Successfully outsourcing your translationactivities• Understanding the key challenges experienced by industry whenoutsourcing translation

• Examining suggestions to overcome these challenges• Effectively reviewing translations in an limited timeframe • Effectively co-ordinating translation tasksFacilitated by: Patricia Lefebvre, Head, Internal MedicineTherapeutic Domain, Global Labeling, Sanofi, France

16.35 End of conference day two

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One of the key challenges facing labelling professionals is the international variability in requirements related to pharmaceutical labelling. Focusing on the US, thisevening briefing will focus on understanding and complying with labelling requirements as well as proving a comparison between the EU and US. Clearlyunderstanding country –specific requirements is essential for delivering appropriately labelling products in a cost and time-efficient manner.

Media Partners:

PROMOTIONAL OPPORTUNITIESUse this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

• Use an exhibition stand to meet new clients in the main networking area • Raise your corporate profile and shape your corporate image with logo placementLaunch new products and ensure market presence as a thought leader with a speaking slot • Develop new client relationships and affirm existing ones with your presence at the event

We have a wide range of tailored sponsorship solutions, to find out more please contact:Linda Cole, Business Development Manager, Tel: +44 (0) 20 7017 6631 Email: linda.cole@informa.com

Enhance your profile further with 2 events and 1 exhibition room. Co-located with Labelling Compliance for Medical Devices and IVDs