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ConferenCe 8 & 9 june 2011 Copenhagen

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CLInICAL trIAL SAfety & pHArMACoVIGILAnCe

• MHr A (uK): Inspect ion trends

• Henri Mondor Hospita l /ApHp (f): new Individual Case Safety report (ICSr)

• Sidley Aust in LLp (uK): Data privacy versus Drug Safety

• Danish Medical Agency (DK): Changes in eu pharmacovigi lance Legis lat ion

• Leo pharma A /S (uK /DK): Inspect ion – Industry perspect ive

• ebsteinBeckerGreen (uS): uS pharmacovigi lance Legis lat ion & regulat ion

Chairman of the Conference: Deputy Qp pV Gro Laier, novo nordisk A/S

UPDATE on legislation and latest industry experience

In cooperation with

www.ibceuroforum.dk

. . . AnD MAny otHer SpeAKerS AnD BuSIneSS CrItICAL ISSueS!

More neW upDAteS In tHe proGrAMMe...

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To register www.ibceuroforum.dk/edir

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professional and complete range of pharmacovigilance servicesSome of our expert areas are:• Data entry and case evaluation• Case distribution• Sop-writing• Literature surveillance

We cover clinical trials and post-marketing

We provide:• project management• Ourserviceson-siteorfromourownoffices

for further services please visit www.a-consult.com

SpeAKerS ChiefMedicalOfficer Doris Stenver Danish Medical agency (DK)

Deputy Qp pV gro Laier novo nordisk a/S (DK)

Dr. jur. & dr. med. adem Koyuncu Mayer Brown LLp (De)

head of pharmacovigilance Department hervé le Louet henri Mondor hospital / aphp (F)

principal Clinical Drug Safety adviser peter astrup Fejerskov aLK-abelló a/S (DK)

William RM Long Sidley austin LLp (UK)

Director of Safety Medical Writing pilar Carrero novo nordisk a/S (DK)

Member of the Firm Benjamin S. Martin ebsteinBeckergreen (US)

Dr. phD pharmacovigilance Inspector Dominic nguyen-Van-Tam MhRa (UK)

Internal Consultant Compliance Ian oulsnam Qa gCp, gpvp & gLp Compliance Leo pharma a/S (UK/DK)

Director, M.Sc.Dent, DDS erik Malte Rasmussen DataService and Lindeq (DK)

Director, global pharmacovigilance Tina elberling Leo pharma a/S (DK)

Manager & Senior Specialist Flemming Kjær Jørgensen a-consult a/s (DK)

Director, pharmacovigilance ea Dige aLK-abelló a/S (DK)

Chairman:Deputy Qp pV gro Laier novo nordisk a/S (DK)

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CLInICAL trIAL SAfety & pHArMACoVIGILAnCe UPDATE on legislation and latest industry experience

Key topICS• new eU pharmacovigilance Legislation: Which are the major changes & implications?• eudraVigilance expert Working group – new IMe list• Data privacy versus Drug Safety – what to do?• From annual Safety Report to DSUR (Development Safety Update Report)• Recent US legislation & regulation on pharmacoviligance• Trends from inspections – MhRa & industry experiences• Signal detection – recent development and trends• new Individual Case Safety Report (ICSR)• Cross-organisational Safety Risk Management (SRM)• Insourcing and outsourcing of pharmacovigilance activities – advantages and pitfalls• Discussion: pharmacovigilance setup in BRIC countries

Key SpeAKerS• Dr. phD pharmacovigilance Inspector Dominic nguyen-Van-Tam MhRa (UK) • William RM Long, Sidley austin LLp (UK) • head of pharmacovigilance Department hervé le Louet, henri Mondor hospital / aphp (F)• ChiefMedicalOfficerDorisStenver,DanishMedicalAgency(DK)• Dr. jur. & dr. med. adem Koyuncu, Mayer Brown LLp (De)• Internal Consultant Compliance Ian oulsnam, Qa gCp, gpvp & gLp Compliance,

Leo pharma a/S (UK/DK)• Member of the Firm Benjamin S. Martin ebsteinBeckergreen (US)

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CLInICaL TRIaL SaFeTy & phaRMaCoVIgILanCe

08.30 registration

Morning coffee/tea

09.00 organizer’s welcome remarks

Senior Project Manager Rikke Ryge Casper, IBC Euroforum

09.05 Chairman’s opening remarks

Deputy Qp PV Gro Laier, Novo Nordisk A/S (DK)

neW eu pHArMACoVIGILAnCe LeGISLAtIon

09.10 new eu pharmacovigilance Legislation: Which are the major changes?

• Clarificationofrolesandresponsibilities• Strengthening the risk-adjusted approach • Improved Communication and Transparency

Chief Medical Officer Doris Stenver, Danish Medical Agency (DK)

09.55 Break

10.10 new eu pharmacovigilance Legislation: Industry perspective

Deputy Qp PV Gro Laier, Novo Nordisk A/S (DK)

10.40 new eu pharmacovigilance Legislation: Legal perspective

Dr. jur. & dr. med. Adem Koyuncu, Mayer Brown LLP (DE)

Adem Koyuncu is double-qualified as lawyer and medical doctor and is a partner at the law firm Mayer Brown LLP in Cologne. As lawyer, he advises pharma companies on regulatory, pharmacovigilance and liability matters. Before joining Mayer Brown he worked for several years in the pharma industry.

11.10 Discussion: new eu pharmacovigilance Legislation

Chief Medical Officer Doris Stenver, Danish Medical Agency (DK)

Deputy Qp PV Gro Laier, Novo Nordisk A/S (DK)

Dr. jur. & dr. med. Adem Koyuncu, Mayer Brown LLP (DE)

11.25 Break

Day 1 • WeDnesDay 8 June 2011

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ADVerSe reACtIon reportInG

11.40 Adverse reaction reporting – new & recent eu regulation

• expected changes to the ICSR reporting in the context of the new pharmacovigilance legislation

• and more...

Head of Pharmacovigilance Department Hervé le Louet, Henri Mondor Hospital / APHP (F)

12.10 eudraVigilance expert Working Group – new IMe list

The eudraVigilance expert Working group has co-ordinated the development of an Important Medical event Terms (IMe) list

• The list of IMes • The criteria behind the list• how is the list to be used?

Principal Clinical Drug Safety Adviser Peter Astrup Fejerskov, ALK-Abelló A/S (DK)

12.45 Lunch

13.35 Data privacy vs. Drug Safety

Uncertainties continue to exist in how to reconcile eU regulatory requirements for pharmacovi-gilance reporting and data protection. This session considers:

• Recent developments in pharmacovigilance and data protection • Latest views of the european regulators • Responding to the eMa data protection survey • Dealing with data subject rights including subject access • Reform of the eU’s data protection regime

William RM Long, Sidley Austin LLP (UK)

William RM Long advises international clients on a wide variety of data protection, privacy, information security, e-commerce, payments and other regulatory matters. Mr. Long has experience with EU and international data protection and privacy projects particularly in the financial services and healthcare sectors advising on cross-border data transfer and other data protection issues.

14.20 Break

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Day 1 • WeDnesDay 8 June 2011 Day 1 • WeDnesDay 8 June 2011

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CLInICaL TRIaL SaFeTy & phaRMaCoVIgILanCe

Day 1 • WeDnesDay 8 June 2011 Day 2 • ThursDay 9 June 2011

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DeVeLopMent SAfety upDAte report (DSur)

14.35 from Annual Safety report to DSur (Development Safety update report)

• a new document to harmonise periodic safety reporting during clinical trials • ICh e2F – Where are we now from a regulatory perspective? • DSUR content – what is new compared to annual Safety Reports? • how big will the workload/burden be?

Director of Safety Medical Writing Pilar Carrero, Novo Nordisk A/S (DK)

15.25 Break

uS LeGISLAtIon

15.40 uS legislation and regulation on pharmacoviligance

• new FDa legislation • FDa’s Sentinel Initiative

Member of the Firm Benjamin S. Martin, EbsteinBeckerGreen (US)

Benjamin S. Martin is part of the Health Care and Life Sciences practice in the firm’s Washington DC office, where he practices in the Pharmaceutical Industry Health Regulatory Group. Mr. Martin provides regulatory counseling and litigation support on a wide range of issues affecting pharmaceutical and medical device manufacturers

16.25 Chairman’s closing remarks

16.30 end of conference day one

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Day 1 • WeDnesDay 8 June 2011

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Day 2 • ThursDay 9 June 2011

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08.30 Morning coffee/tea

09.00 Chairman’s opening remarks

Deputy Qp PV Gro Laier, Novo Nordisk A/S (DK)

InSpeCtIon

09.05 trends from MHrA inspections

• Background to MhRa pV Inspections• Types of inspections• The inspection process• Commonfindings

Dr. PhD Pharmacovigilance Inspector Dominic Nguyen-Van-Tam, MHRA (UK)

10.00 Break

10.15 GCp and Gpvp inspections – an industry perspective

Internal Consultant Compliance Ian Oulsnam, QA GCP, GPvP & GLP Compliance, Leo Pharma A/S (UK/DK)

Ian Oulsnam worked for MHRA 1998-2010 setting up the UK National GCP inspection Programme and was Operations manager for GCP inspections and then Expert inspector. He was involved in early GPvP inspections in UK, and participated in the routine review of critical findings from MHRA GCP and PvP inspections. Ian is active at EMA inspectors working group and led 3 EMA inspections. Ian previously worked in QA audit roles for companies such as GlaxoWellcome and Pfizer

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Day 2 • ThursDay 9 June 2011 Day 2 • ThursDay 9 June 2011

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CLInICaL TRIaL SaFeTy & phaRMaCoVIgILanCe

11.00 Break

SIGnAL DeteCtIon

11.15 Signal detection – recent development and trends

• Why perform Signal Detection? • Standards in the area (without the sophisticated mathematical formulas) • Comparator data – in-house or external?• new approaches• available off-the-shelf (oTS) solutions

Director, M.Sc.Dent, DDS, Erik Malte Rasmussen, DataService and Lindeq (DK)

Erik Malte Rasmussen has more than 20 years working experience from international pharmaceutical companies (e.g. LEO Pharma, H. Lundbeck and Nycomed) as a specialist and as a line manager in drug safety systems management, pharmacovigilance and clinical development. He is experienced with identification, development and deployment of signal detection processes.

12.00 Lunch

rISK MAnAGeMent In prACtISe

13.00 Cross-organisational Safety risk Management (SrM)

• external and internal drivers for SRM • Collaboration with all stakeholders • SRM processes • SRM governance

Director, Global Pharmacovigilance, Tina Elberling, LEO Pharma A/S (DK)

13.45 Break

SourCInG QppV

14.00 Insourcing and outsourcing of pharmacovigilance Activities – Advantages and pitfalls

Corporate management of safety of medicines has in recent years achieved great strategic importance. public attention and regulatory requirements have been increased, and it sets pharmacovigilance departments under increasing pressure.

• Can in- and outsourcing of pharmacovigilance activities be an asset in company planning? • Whatbenefitscanbeachievedandwhichpitfallsshouldbeavoided?• experiences of consultants and companies

Day 2 • ThursDay 9 June 2011

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Sponsorship & exhibition Space

a range of tailored sponsorship & exhibition options are available to suit your needs including corporate sponsor, lunch sponsor, cocktail sponsor & exhibition sponsor.please contact: Sarah elhauge, phone: (+45) 35 25 35 45 or e mail: spex@ibceuroforum.dk

Manager & Senior Specialist Flemming Kjær Jørgensen, A-consult a/s (DK)

14.45 Break

pHArMACoVIGILAnCe In BrIC CountrIeS

15.00 pAneL DISCuSSIon: pharmacovigilance setup in BrIC countries

Director of Pharmacovigilance Ea Dige, ALK-Abelló A/S (DK) Deputy Qp PV Gro Laier, Novo Nordisk A/S (DK) And others..

15.55 Chairman’s closing remarks

16.00 end of conference

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WHo WILL AttenD?Vp’s, Directors, Heads, Managers, Advisors, Consultants of:

• pharmacovigilance• pharmacoepidemiology• pharmacogenomics• Drug/product Safety• Drug Development• Information and Clinical Data Management• Clinical pharmacology• Clinical Safety • periodical safety update report • Risk Management• Research & Development• Quality assurance• patient Safety • Signal Detection• Safety Surveillance• outcomes Research• Data analysis• epidemiology • Medical affairs• Regulatory affairs and Compliance • Information technology • Sales and Marketing

We take reservations for misprints and changes in the programme. For further information please contact Senior project Manager Rikke Ryge Casper phone: +45 4195 1429 or e-mail: rc@ibceuroforum.dk

Regulatory Affairs

Medical Director/Advisor

Pharmacovigilance Manager/ Officer / Specialist

QA Manager / Advisor / SpecialistSafety Manager / Officer / Advisor / Assistant

Trial Manager

Auditor

CEO / Partner / Vice President

14 %

18 %

10 %

5 %

29 %

7 %

7 %11 %tArGet AuDIenCe BASeD on

DeLeGAte joB tItLeS froM our preVIouS pHArMACoVIGILAnCe ConferenCeS

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Venue AnD reGIStrAtIon Dates and Conference Venue ”Clinical Trial Safety & pharmacovigilance” will take place 8 and 9 June 2011 at Radisson Blu Falconer hotel & Conference Center, Falkoner allé 9, 2000 Frederiksberg C (Copenhagen), phone (+45) 38 15 80 01.

Accommodation accommodation is not included in the registration fee. please contact Radisson Blu Booking for room reserva-tion, phone: (+45) 38 15 65 00. please disclose CFT no: 62615.

parking If arriving by car, please reserve a space in the hotel underground car park. additional parking is available at Falconer Square placed close to the venue. one-day parking permission can be bougt from the hotel reception for DKK 35. please note: IBC euroforum is not responsible for any parking violations that you receive while attending the event. It is easy to travel by public transport system Metro to Frederiksberg Station, which is situated very close to the venue.

registration fee All fees are exclusive VAT.

Registration by 30 april

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Conference DKK 11,995 DKK 2,000 DKK 12,995 DKK 1,000 DKK 13,995

The registration fee includes all sessions, lunch, refreshments and available documentation.

registration Toregisterfortheconferencethebestandquickestwayistofillintheonlineregistrationformon www.ibceuroforum.dk/edir. We also accept bookings by post, phone: (+45) 35 25 35 45, fax (+45) 35 25 35 46 or e-mail: registration@ibceuroforum.dk. once we have received your registration you will receive an invoice andaconfirmationwhichcontainsusefulinformation.Yourregistrationisbinding.

Cancellation all cancellations must be submitted in writing. all cancellations received by 24 May 2011 are subject to an administrative charge of 10 percent of the registration fee. all cancellations received between 24 May and 5 June 2011 are subject to an administrative charge of 50 percent of the registration fee We regret that cancellati-ons received after 5 June 2011 cannot be refunded or credited and the full fee will be due for aLL registrations submitted. Substitute delegates are welcome at any time. all substitutions must be received in writing.

IBC euroforum apS, Silkegade 17, st., postboks 2023, 1012 København K, Telefon (+45) 35 25 35 45, Fax (+45) 35 25 35 46, info@ibceuroforum.dk, www.ibceuroforum.dk, giro 3 93 14 55, VaT registered no 24 24 03 71

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CLInICAL trIAL SAfety & pHArMACoVIGILAnCe