Pharmacovigilance 2015

UPDATE on legislation & prac tical implications

Pharma covigilance Conference 10 & 11 March 2015 Copenhagen

INDUSTRY CASE STUDIES AstraZeneca (UK) | Novo Nordisk (DK) | MSD (B) | Takeda (UK) | Merck Research Laboratories (DK) | GlaxoSmithKline Vaccines (B)

EXPERTISE Horten | Danish Health and Medicines Authority

In coorporation with:

www.ibceuroforum.dk/pv

Speakers CHAIRMAN

INDUSTRY

PV Policy Expert Gro Laier NOVO NORDISK A/S (DK)

Systems Area Lead Alastair Fowkes ASTRAZENECA (UK)

AUTHORITIES & ADVISORS

EU Regional Director Epidemiology Michael Busch-Sørensen MERCK RESEARCH LABORATORIES (DK)

Special Advisor Line Michan Pharmacovigilance & Medical Devices DANISH HEALTH AND MEDICINES AUTHORITY (DK) Former PV Inspector, MSc Pharm Anna Toth (S) Lawyer, partner Martin Dræbye Gantzhorn HORTEN (DK)

PV Policy Expert Gro Laier NOVO NORDISK A/S (DK) Safety Surveillance Principal Specialist Birgitte Scharling NOVO NORDISK A/S (DK) Executive Director, EU QPPV Dr. Guy Demol MSD (B) Safety Surveillance Risk Management Specialist Samuel Ramsden NOVO NORDISK A/S (DK) Director, Deputy EU QPPV Jean Kilgour-Christie TAKEDA DEVELOPMENT CENTRE EUROPE LTD (UK) NEW SPEAKER Safety Scientist Valentina Attanasi GLAXOSMITHKLINE VACCINES (BELGIUM)

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Pharmacovigilance Legislation & practical implications KEY TOPICS

• • • • • • • • • •

Pharmacovigilance Risk Assessment Committee (PRAC) – what’s up?

Post-Authorisation Studies – update on PASS & PAES Status on new GVP Modules – Module XI & Module XII Implementation of Clinical Trial Regulation – impact on safety & regulatory challenges Module XVI Risk Minimisation Measures – implementation in practice Important Risks & Risk Management Plans (RMP) Periodic Safety Update Reports (PSUR) Module VI Management & Reporting of Adverse Reactions – implementation of E2B(R3) Improved signal detection and management for more effective Pharmacovigilance Pharmacovigilance System Master File (PSMF) – authority experiences

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

We cover clinical trials and post-marketing

• • • • •

We provide:

Single case handling Report writing (RMP, PSUR) SOP writing Literature surveilance Guidance on PV requirements

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

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

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Pharmacovigilance Legislation & practical implications WHO WILL ATTEND? VP’s, Directors, Heads, Managers, Advisors, Officers and Consultants of: Pharmacovigilance • Pharmacoepidemiology • Pharmacogenomics • Drug/Product Safety • Drug Development • Information and Clinical Data Management • Clinical Pharmacology • Clinical Safety • Risk Management • Research & Development • Quality Assurance • Patient Safety • Signal Detection • Safety Surveillance • Outcomes Research • Data Analysis • Epidemiology • Medical Affairs • Regulatory Affairs & Compliance • Information technology • Sales & Marketing Target audience based on Delegate job titles from our previous pharmacovigilance conferences

7%

Regulatory Affairs Medical Director / Advisor

5%

11 %

7%

14 %

Pharmacovigilance Mananger/Officer/Specialist QA Manager/Advisor/Specialist Safety Manager/Officer/Advisor/Assistant Trial Manager Auditor CEO/Partner/ Vice President

18 %

29 % 10 %

We take reservations for misprints and changes in the programme. For further information please contact Senior Project Manager Rikke Ryge Casper, Tel: (+45) 4195 1429 or e-mail: rc@ibceuroforum.dk 4 | Pharmacovigilance 2015

PROGRAMME | TUESDAY 10 MARCH 2015 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 PV Policy Expert Gro Laier, Novo Nordisk A/S (Denmark)

RISK MINIMISATION MEASURES 09.10

Module XVI – Risk Minimisation Measures – implementation in practice • Implementation of GVP module XVI and the impact on the Novo Nordisk risk management system and risk management plans Safety Surveillance Risk Management Specialist Samuel Ramsden, Novo Nordisk A/S (Denmark)

09.55

Break

10.10

Important Risks and Risk Management Plans (RMP) • What is an important risk, what is an adverse drug reaction?

• Where to focus on in the RMP? • Important risks and life cycle management of the RMP Executive Director, EU QPPV for Risk Management & Pharmacovigilance Dr. Guy Demol, MSD (Belgium)

11.00

Break

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PROGRAMME | TUESDAY 10 MARCH 2015 POST-AUTHORISATION STUDIES 11.10

Opdated Module VIII – Post-Authorisation Safety Studies (PASS) • PASS definition industry issues • PASS presentation in RMPs industry issues • PASS study design some reflections PV Policy Expert Gro Laier, Novo Nordisk A/S (Denmark)

12.00

Lunch

13.00

Updated guidance on Post-Authorisation Efficacy Studies (PAES) • PAES regulatory overview • PAES status on implementation • PAES and PASS/HTA issues EU Regional Director Epidemiology Michael Busch-Sørensen, Merck Research Laboratories (DK)

13.45

Break

CLINICAL TRIAL REGULATION 14.00

Implementation of Clinical Trial Regulation – impact on safety • Definitions – what is new?

• Interface with GVP requirements • New concept “low-intervention clinical trial” Safety Surveillance Principal Specialist Birgitte Scharling, Novo Nordisk A/S (Denmark) Lawyer, partner Martin Dræbye Gantzhorn, Horten (Denmark)

15.00

Chairman’s closing remarks

15.15

End of conference day one

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PROGRAMME | WEDNESDAY 11 MARCH 2015 08.30

Morning coffee/tea

09.00

Chairman’s opening remarks

NEWS FROM EU REGULATORS 09.05

Status on new GVP Modules • Module XI – Public participation in pharmacovigilance • Module XII – Continuous pharmacovigilance, ongoing benefit-risk evaluation, regulatory action and planning of public communication Speaker to be announced

10.00

Break

10.15

Module VI – Management and Reporting of Adverse Reactions to Medicinal Products Implementation of E2B(R3) Electronic Transmission of Individual Case Safety Reports Systems Area Lead Alastair Fowkes, AstraZeneca (UK) Alastair Fowkes is the EFPIA topic lead for the ICH E2B(R3) Implementation Working Group.

11.00

Break

11.10

Pharmacovigilance Risk Assessment Committee (PRAC) - what’s up?

• Status on the work within the PRAC Committee • Present focus of the PRAC Committee, e.g. Biological Pharma, Risk Minimisation, Measurement of effectivity Special Advisor Line Michan, Pharmacovigilance & Medical Devices, Danish Health and Medicines Authority (Denmark)

12.00

Lunch

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PROGRAMME | WEDNESDAY 11 MARCH 2015 PERIODIC SAFETY UPDATE REPORTS 13.00

Periodic Safety Update Reports (PSUR) – the current Challenges • Managing the PBRER/PSUR globally • Managing the PRAC process for PSURs Director, Deputy EU QPPV Jean Kilgour-Christie, Global Pharmacovigilance, Takeda Development Centre Europe Ltd (UK)

13.50

Break

INDUSTRY PERSPECTIVE 14.05

Improved signal detection and management for more effective Pharmacovigilance • Creating a robust signal detection process capable of early detection of adverse reactions • Regulatory guidance on signal management • Knowing which algorithms you should use for the most accurate signal detection results • Applying signal detection during post-market surveillance Safety Scientist Valentina Attanasi, GlaxoSmithKline Vaccines (Belgium)

14.50

Break

PHARMACOVIGILANCE SYSTEM MASTER FILE 15.05

Pharmacovigilance System Master File (PSMF) • Experiences from Authorities on received PSMFs • Comments to companies from the Authorities Former PV Inspector, MSc Pharm Anna Toth (Sweden) Anna Toth has 30 years of experience in pharmacovigilance and 6 years as pharmacovigilance inspector and manager within the Swedish Medical Products Agency. As a delegate in the European Medicine Agency (EMA) Pharmacovigilance Inspectors Working Group she has also worked to compile and establish Good Vigilance Practice in EU.

15.50

Chairman’s closing remarks

16.00

End of conference

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UPDATE on legislation & prac tical implications

Pharma covigilance

Pharmacovigilance 2015 | 9

VENUE AND REGISTRATION DATES AND CONFERENCE VENUE Pharmacovigilance 2015 will take place on 10-11 March 2015 at Hotel Skt. Petri, Krystalgade 22, DK-1172 Copenhagen K, Denmark, Tel: (+45) 33 45 91 00.

ACCOMMODATION Accommodation is not included in the registration fee. Please contact Hotel Skt. Petri for room reservation, Tel: (+45) 33 45 91 00 and refer to participation at the conference.

PARKING It might be difficult to find a parking space around Hotel Skt. Petri, however, the hotel is easily reached by train or metro (Nørreport Station) which is about 5 minutes away. Please note: IBC Euroforum is not responsible for any parking violations that you receive while attending the event.

REGISTRATION FEE

All fees are exclusive VAT.

EARLY BIRD! Registration by 6 February DKK 12,495

Registration by 27 February DKK 13,495

Registration after 27 February DKK 14,495

IF YOU ARE MORE THAN ONE FROM YOUR COMPANY, PLEASE CONTACT US FOR AN OFFER. The registration fee includes all sessions, lunch, refreshments and available documentation.

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REGISTRATION To register for the conference the best and quickest way is to fill in the online registration form on www.ibceuroforum.dk/pv. We also accept bookings by post, Tel: (+45) 35 25 35 45 and e-mail: registration@ibceuroforum.dk. Once we have received your registration you will receive an invoice. Your registration is binding.

CANCELLATION All cancellations must be submitted in writing. All cancellations received by 24 February 2015 are subject to an administrative charge of 10 percent of the registration fee. All cancellations received between 24 February and 6 March 2015 are subject to an administrative charge of 50 percent of the registration fee We regret that cancellations received after 6 March 2015 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., Postbox 2023, DK-1012 Copenhagen K, Tel: (+45) 35 25 35 45, info@ibceuroforum.dk, www.ibceuroforum.dk, Giro 3 93 14 55, VAT registered No 24 24 03 71

Pharmacovigilance 2015 | 11

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

REGISTR ATION FOR M PHARMACOVIGILANCE 2015

Copenhagen • Conference • 10 & 11 March 2015 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 FEE

4 WAYS TO REGISTRER (+45) 35 25 35 45

Registration by 27 February DKK 13,495

Registration after 27 February DKK 14,495

Please disclose the registration code written in the address field www.ibceuroforum.dk/pv registration@ibceuroforum.dk

IBC Euroforum Silkegade 17, st.

DK-1113 Copenhagen K

15pv

EARLY BIRD

Registration by 6 February DKK 12,495

All fees are exclusive VAT