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Conference 14 & 15 junE 2012 Copenhagen

pHARMACOVIGILANCE UPDATE on legislation & practical implications

EU Pharmacovigilance Legislation • Update, overview & status • Practical implications, challenges & experiences

2012

Development Safety Update Report • What can be learned from the first submissions?

Data privacy & Drug Safety ...and many other business critical issues

Key speakers from national authorities & industry Danish Medicines Agency (DK), Medical Products Agency (S), Norwegian Medicines Agency (N), European Confederation of Pharmaceutical Entrepreneurs (B), Johnson & Johnson (S), H. Lundbeck (DK), Novo Nordisk (DK), ALK-Abelló (DK), Nycomed (DK), Covington & Burling (UK), Pope Woodhead and Associates Ltd (UK)

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

SPEAKERS Legal Counsel Matthias Heck European Confederation of Pharmaceutical Entrepreneurs (B) Director of Pharmacovigilance Ea Dige ALK-Abelló (DK) Project Manager Jakob Ellinshøj Larsen Novo Nordisk (DK) Chief Medical Officer Dr. Doris I. Stenver Danish Medicines Agency (DK) Nordic Drug Safety Manager Dr. Julia Appelskog Johnson & Johnson (S) MD, PhD, Clinical Assessor Lennart Waldenlind Signal Detection Medical Products Agency (S) Head of Surveillance Section Dorthe Sauerland H. Lundbeck (DK)

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Head of Pharmacovigilance Ingebjørg Buajordet Norwegian Medicines Agency (N) Partner Grant H. Castle Covington & Burling LLP, London (UK) Senior Consultant Dr Steve Hutson Pope Woodhead and Associates Ltd Head of Medical Safety Evaluation Claudia Pierleoni-Nielsen Nycomed (DK)

Chairman: Deputy Qp PV Gro Laier Novo Nordisk (DK)

pHARMACOVIGILANCE

UPDATE on legislation & practical implications Key topics • EU Pharmacovigilance Legislation – overview & status • The Mandate of the new Pharmacovigilance Risk Assessment Committee (PRAC) • Implementation of EU Pharmacovigilance Legislation in practice – challenges & experiences of authorities & industry • Data privacy & Drug Safety • Submission of Development Safety Update Report – experiences of authorities & industry

Key speakers • Legal Counsel Matthias Heck, European Confederation of Pharmaceutical Entrepreneurs (B) • Chief Medical Officer Dr. Doris I. Stenver, EU Pharmacovigilance Working Party Delegate, Danish Medicines Agency (DK) • MD, PhD, Clinical Assessor Lennart Waldenlind, Signal Detection, Medical Products Agency (S) • Head of Pharmacovigilance Ingebjørg Buajordet, Norwegian Medicines Agency (N) • Partner Grant H. Castle, Covington & Burling LLP, London (UK) • Senior Consultant Dr Steve Hutson, Pope Woodhead and Associates Ltd (UK) • Nordic Drug Safety Manager Dr. Julia Appelskog, Johnson & Johnson (S)

Professional and complete range of pharmacovigilance services Some 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 • Our services on-site or from our own offices

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

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Day 1 • Thursday 14 June 2012 PHARMACOVIGILANCE – Update on legislation & practical implications

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 (DK)

NEW EU PHARMACOVIGILANCE LEGISLATION – overview & implications in general 09.10

EU Pharmacovigilance Legislation – overview & status An overview of the new legislation that will apply from July 2012 • Strengthening of post-authorisation regulation of medicines • Improvement of efficiency • Increase of transparency Good Pharmacovigilance Practices (GVP) guidelines – schedule & status • The first batch of good pharmacovigilance practices (GVP) guidelines • The expected second batch of good pharmacovigilance practices (GVP) guidelines • Status of guidelines – how to interpret should, shall, recommend etc?

Challenges and experiences so far Legal Counsel Matthias Heck, European Confederation of Pharmaceutical Entrepreneurs (B)

10.05

4

Break

Day 1 • Thursday 14 June 2012 PHARMACOVIGILANCE – Update on legislation & practical implications

INDUSTRY

10.20

INDUSTRY

11.00

11.40

An industry approach to the new legislation – what to do, how to prioritise?

• Where are we in relation to 2 July 2012?

• How have we approached the new legislation – the plan to addapt?

• What has worked, what has not?

• What is most important – what comes first, what has been postponed?

Director of Pharmacovigilance Ea Dige, ALK Abelló (DK) How to manage the challenge of implementation?

• The Project Process • Largest gaps identified • Key learnings for next wave Project Manager Jakob Ellinshøj Larsen, Novo Nordisk (DK) Break

NEW EU PHARMACOVIGILANCE LEGISLATION – implementation in practise 11.50

The new Pharmacovigilance Risk Assessment Committee (PRAC) • Mandate and tasks • Interactions with CHMP and CMD(h) (Coordination Group (human) Chief Medical Officer Dr. Doris I. Stenver, EU Pharmacovigilance Working Party Delegate, Danish Medicines Agency (DK) RMP Risk Management Systems & PSUR Periodic Safety Update Reports • Guidance and expectations from the authorities to the pharmaceutical industry Chief Medical Officer Dr. Doris I. Stenver, EU Pharmacovigilance Working Party Delegate, Danish Medicines Agency (DK)

13.00

Lunch

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Day 1 • Thursday 14 June 2012 PHARMACOVIGILANCE – Update on legislation & practical implications

INDUSTRY

14.00

Effective risk management plan – a practical approach • Effective risk management plan – a practical approach • What are the new requirements for risk management plan?

• Incorporation of developmental, clinical and epidemiological safety data combined with post market surveillance to ensure product safety • Effectiveness of risk minimisation measures • Evaluation of potential and identified risks • Communicating safety and comparative benefit/risk • Pragmatic and realistic local implementation Nordic Drug Safety Manager Dr. Julia Appelskog, Johnson & Johnson (S)

14.45

Break

15.00

Signal Management & Reporting on Adverse Reactions Signal management – new requirements according to GVP IX • New ADRs vs. increased frequency of known ADRs • Statistical and descriptive methods • Logistical implications • Importance of regulatory procedure Individual case safety reporting (ICSR) • New legislation • Transitional requirements • Country-specific requirements • Consumer reports MD, PhD, Clinical Assessor Lennart Waldenlind, Signal Detection, Medical Products Agency (S)

INDUSTRY

16.00

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ICSR – major key practical implications • Practical implications of new ICH Individual Case Safety Report (ICSR) Head of Section Dorthe Sauerland, Safety Surveillance Section, H. Lundbeck (DK)

16.45

Chairman’s closing remarks

17.00

End of conference day one

Day 2 • Friday 15 June 2012 PHARMACOVIGILANCE – Update on legislation & practical implications

08.30

Morning coffee/tea

09.00

Chairman’s opening remarks

NEW EU PHARMACOVIGILANCE LEGISLATION – implementation in practise .... CONTINUED 09.05

Pharmacovigilance systems master files • What is the difference between a PhV master file and a DDPS? • The transitional period Head of Pharmacovigilance Ingebjørg Buajordet, Norwegian Medicines Agency (N) Post-authorisation safety studies (PASS) How will the new legislation affect the following: • Preparing of the study protocol?

• Interaction with competent authorities?

• Which adverse drug reactions are reportable to authorities and how?

• Handling of the study report?

Head of Pharmacovigilance Ingebjørg Buajordet, Norwegian Medicines Agency (N) Break

10.25

Pharmacovigilance Quality System • What is a (iso) quality system – what does it take?

• How to establish a quality system?

• Where to start?

Speaker to be announced

INDUSTRY

10.15

11.15

Break

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Day 2 • Friday 15 June 2012 PHARMACOVIGILANCE – Update on legislation & practical implications

Data privacy & Drug Safety 11.25

Data Privacy & Drug Safety • What is allowed?

• What is not?

• Where are the pitfalls (findings from audits)?

PhD, Partner Grant H. Castle, Covington & Burling LLP, London (UK) Grant Castle is a Partner in the London office of Covington & Burling LLP practicing in the areas of pharmaceutical and medical devices regulatory law and associated data protection laws. He has assisted clients with a variety of regulatory procedures including formal and informal good manufacturing practices (GMP), good clinical practices (GCP), advertising, borderline, drug safety and pharmacovigilance proceedings before the European Medicines Agency (EMEA), national authorities and courts.

12.15

Lunch

Development Safety Update Report (DSUR) 13.15

Development Safety Update Report – the submission of the first DSURs • Experiences since September 2011 • Are there going to be Assessment Reports?

• How can they be improved?

• Is the pharmaceutical industry doing an adequate job with regards to the content and format of the DSUR? • MAHs are requested to provide an overall evaluation of the efficacy of the drug during the clinical development programme – which focus points and expectations from authorities?

Senior Consultant Dr Steve Hutson, Pope Woodhead and Associates Ltd (UK) Before joining Pope Woodhead Steve was working in the biopharmaceutical industry as a manager of operational units and as an interim manager. As he has headed pharmacovigilance, clinical data management, medical information and IT departments and has also worked as the QP PV/deputy QP PV for a number of pharmaceutical organisations, Steve has a good knowledge of the changing regulatory landscape. As an interim Steve also planned and delivered a wide variety of IT projects and compliance inspections (GCP, ICH, GDP/GMP, 21CFR part 11 and SOx

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Day 2 • Friday 15 June 2012 PHARMACOVIGILANCE – Update on legislation & practical implications

INDUSTRY

14.10

DSUR Experiences of the Industry • General Principles • Current challenges and FAQs - Resource demands – how many involved?

- What does it take?

• Few examples of DSUR for compounds in early and late stage development Head of Medical Safety Evaluation Claudia Pierleoni-Nielsen, Nycomed: a Takeda Company

14.50

Chairman’s closing remarks

15.00

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 9

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 Pharmacovigilance 2012 takes place on 14 and 15 June 2012 at Radisson Blu Falconer Hotel & Conference Center, Falkoner AllĂŠ 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 27 April

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Registration by 25 May

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Registration after 25 May

DKK 12,495

DKK 2,000

DKK 13,495

DKK 1,000

DKK 14,495

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 31 May 2012 are subject to an administrative charge of 10 percent of the registration fee. All cancellations received between 31 May and 11 June 2012 are subject to an administrative charge of 50 percent of the registration fee We regret that cancellations received after 11 June 2012 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 11

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

delegate details pHARMACOVIGILANCE 2012 Copenhagen • Conference • 14 & 15 June 2012 Name Job Title Department E-mail Would you like to recieve information on future events by e-mail?  Yes please

 No thank you

Name of Company Address Postcode & City Phone VAT reg No Name of assistant Name of immediate superior  I am unable to attend the conference. Please send me the speaker presentations (DKK 2,495 exclusive VAT).

registration fees Save

Registration by 25 May

Save

Registration after 25 May

DKK 12,495

DKK 2,000

DKK 13,495

DKK 1,000

DKK 14,495

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

21405

Conference

All fees are exclusive VAT

Registration by 27 April