CLINICAL TRIAL SAFETY & PHARMACOVIGILANCE

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Conference 8 & 9 junE 2011 Copenhagen

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cLINICAL tRIAL sAFeTy & pHARMACOVIGILANCE

UPDATE on legislation and latest industry experience more NEW updates in the programme...

• MHR A (UK): Inspection Trends • Henri Mondor Hospital/APHP (F): New Individual Case Safet y Repor t (ICS R) • Sidley Austin LLP (UK): Data Privacy versus Drug Safet y • Danish Medical Agency (DK): Changes in EU Pharmacovigilance Legislation • Leo Pharma A /S (UK /DK): Inspection – Industr y Perspective • EbsteinBecker Green (US): US Pharmacovigilance Legislation & NOW confirmed Regulation

Chairman of the Conference: Deputy Qp PV Gro Laier, Novo Nordisk A/S

... And many other speakers and business critical issues !

To register  www.ibceuroforum.dk/edir i samarbejde med In cooperation with www.ibceuroforum.dk

SPEAKERS Chief Medical Officer

Doris Stenver Danish Medical Agency (DK) Deputy Qp PV

Director of Safety Medical Writing

Director, Global Pharmacovigilance

Pilar Carrero

Tina Elberling

Novo Nordisk A/S (DK)

LEO Pharma A/S (DK)

Gro Laier Novo Nordisk A/S (DK) Dr. jur. & dr. med.

Adem Koyuncu

NOW confirmed

Member of the Firm

Benjamin S. Martin EbsteinBeckerGreen (US)

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)

Flemming Kjær Jørgensen A-consult a/s (DK) Director, Pharmacovigilance

Ea Dige

Mayer Brown LLP (DE) Head of Pharmacovigilance Department

Manager & Senior Specialist

NOW confirmed

Dr. PhD Pharmacovigilance Inspector

Dominic Nguyen-Van-Tam MHRA (UK)

ALK-Abelló A/S (DK)

Chairman: Deputy Qp PV

Internal Consultant Compliance

Ian Oulsnam

Gro Laier Novo Nordisk A/S (DK)

QA GCP, GPvP & GLP Compliance Leo Pharma A/S (UK/DK) Director, M.Sc.Dent, DDS

Erik Malte Rasmussen DataService and Lindeq (DK)

Professional and complete range of pharmacovigilance services Some of our expert areas are:

We cover clinical trials and post-marketing

• • • •

We provide:

Data entry and case evaluation Case distribution SOP-writing Literature surveillance

• Project management • Our services on-site or from our own offices

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

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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) NOW confirmed William RM Long, Sidley Austin LLP (UK) Head of Pharmacovigilance Department Hervé le Louet, Henri Mondor Hospital / APHP (F) Chief Medical Officer Doris Stenver, Danish Medical Agency (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) NOW confirmed

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Day 1 • Wednesday 8 June 2011 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?

• Clarification of roles and responsibilities • 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

4

Break

Day 1 • Wednesday 8 June 2011

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 pharmacovigilance 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 CLINICAL TRIAL SAFeTy & pHARMACOVIGILANCE 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) NOW confirmed

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 8 June 2011 Day1 •2 W • Tednesday hursday 9

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 ypes of inspections T The inspection process Common findings

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

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 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?

• What benefits can be achieved and which pitfalls should be avoided?

• Experiences of consultants and companies

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Day 2 • Thursday 9 June 2011

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

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

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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

Target audience based on Delegate job titles from our previous pharmacovigilance conferences

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 5%

11 %

7%

7% 14 %

Regulatory Affairs Medical Director/Advisor Pharmacovigilance Manager/ Officer / Specialist QA Manager / Advisor / Specialist Safety Manager / Officer / Advisor / Assistant Trial Manager Auditor

29 %

CEO / Partner / Vice President

18 %

10 %

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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 reservation, 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

Conference

All fees are exclusive VAT.

Registration by 30 April

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Registration by 20 May

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Registration after 20 May

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 To register for the conference the best and quickest way is to fill in the online registration form on 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 and a confirmation which contains useful information. Your registration is binding.

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 cancellations 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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IBC Euroforum ApS • Silkegade 17, st., • Postboks 2023 • 1012 København K

delegate details cLINICAL tRIAL sAFeTy & pHARMACOVIGILANCE Copenhagen • Conference • 8 & 9 June 2011 Name Job Title Department E-mail Would you like to recieve information on future events by e-mail?

 Yes please

 No thank you

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 I am unable to attend the conference. Please send me the speaker presentations (DKK 2,495 exclusive VAT). registration fees Save

Registration by 20 May

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Registration after 20 May

DKK 11,995

DKK 2,000

DKK 12,995

DKK 1,000

DKK 13,995

5 ways to registrer

Please disclose the registration code written in the address field

(+45) 35 25 35 45

www.ibceuroforum.dk/edir

(+45) 35 25 35 46

registration@ibceuroforum.dk

IBC Euroforum Silkegade 17, st.

1113 København K

21372

Conference

Registration by 30 April