Pharmacovigilance 2016

Conference

17 March 2016 Copenhagen www.insightevents.dk

Post-Authorisation Studies (PASS&PAES) Risk Minimisation

PHARMA COVIGILANCE In cooporation with Grow PV Consulting

Sponsor

PHA RMA COVI GILA NCE 2016

POST AUTHORISATION STUDIES (PASS & PAES) & RISK MINIMISATION Insight Events is once again welcoming you to the annual conference on Pharmacovigilance

This year’s conference will be a one day meeting fully packed with hot topics within Post Authorisation Safety Studies, Post Authorisation Efficacy Studies (PASS&PAES) and Risk Minimization (RMM): • • • • • • • •

RMM and RMM effectiveness evaluation Use of Real World Data, PASS/PAES/imposed registries Multi-county PASS and PAES Use of big data sources in PV – how far are we?

Post authorization monitoring of benefit-risk state of the art?

Regulators perspectives on Risk Minimisation Experience with Risk Minimisation – a healthcare professional’s view” Hot industry/authority discussion

To get a deeper insight of these topics by challenging the experts and creating an interesting and interactive forum for knowledge exchange we have chosen to include two rounds of expert panel discussions.

I’m looking forward to welcoming you at the conference.

Yours sincerely, Louise Starklint Project Manager Insight Events

SPEAKERS

INSIGHT EVENTS

Specialist Adviser Line Michan, Pharmacovigilance and Medical Devices Danish Medicines Agency

Lawyer, Partner Martin Dræbye Gantzhorn Horten

PV Policy Expert Birgitte Scharling NOVO NORDISK A/S

Senior Consultant Martin Holm-Petersen Navitas Life Sciences

Clinical Lead - Medication Safety Ciara Kirke, Quality Improvement Division Health Service Executive (IE)

Senior Researcher Morten Andersen Centre for Pharmacoepidemiology, Karolinska Institutet

Medical Expert Dr Pierre D’Arbigny Sanofi R&D (F) EU Regional Director Epidemiology Michael Busch-Sørensen Merck Research Laboratories

CHAIRMAN:

PV Expert Gro Laier MD Grow PV Consulting

IBC Euroforum has recently changed corporate structure, and we have chosen to use this opportunity to change our company name so that it better reflects our services.

We are now Insight Events.

We have for more than 20 years been offering conferences, courses, training and trade fairs for both the private and public sectors, and our goal is to continue offering our customers new and challenging insights and relevant knowledge in combination with strong networking.

Address and phone numbers are unchanged.

Our new website is www.insightevents.dk

PHA RMA COVI GILA NCE 2016

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 %

Sponsor:

We take reservations for misprints and changes in the programme. For further information please contact Project Manager Louise Starklint, Tel: (+45) 4010 9042 or e-mail: ls@insightevents.dk

A-consult group offers a full range of consulting services within Pharmacovigilance. Whether you are a global pharmacovigilance department or a local affiliate we have the staff to support you.

A-consult group can provide: • Expertise in building and maintaining Pharmacovigilance systems • Writing/updating of documents such as PBRERs, DSURs, Risk Management Plans, PSMFs • Data Entry • Case handling • Literature screening • QPPV function • A full outsourcing solution of your Pharmacovigilance system a-consult.dk/

08.30

Registration

09.00

Organizer’s welcome remarks Project Manager Louise Starklint, Insight Events

09.05

Chairman’s opening remarks PV Expert Gro Laier MD, Grow PV Consulting

PROGRAMME 17 MARCH 2016

RISK MINIMISATION 09.15

Effectiveness and Risk Minimisation Regulator’s experience and expectations Specialist Adviser Line Michan, Pharmacovigilance and Medical Devices, Danish Medicines Agency

10.00

Experience with Risk Minimisation Tools – a healthcare professional’s view

10.45

Coffee break

11.15

EXPERT PANEL DISCUSSION on Risk Minimization • Module XVI Addendum I, Educational materiel, principles and the relation to MP, SPC and PRAC • Risk minimization measures for women of childbearing potential • Measurement of effectiveness PV Policy Expert Birgitte Scharling, NOVO NORDISK A/S Medical Expert Dr Pierre D’Arbigny, Sanofi R&D (F) EU Regional Director Epidemiology Michael Busch-Sørensen, Merck Research Laboratories

12.45

Lunch

Translating risk minimization measures from industry and regulation into safe practices locally is challenging for healthcare professionals and organizations. Reliable systems are required to ensure the appropriate people are aware of recommendations and that they are rapidly incorporated into future practice.

Clinical Lead - Medication Safety Ciara Kirke , Quality Improvement Division, Health Service Executive (IE)

PASS AND PAES DESIGNS 13.45

‘Real World Data’, Usual practice, confounding and randomization is a current discussed mixture PAES scientific guidance, imposed registries, several new regulations being implemented in 2016 and other ‘challenges’ are being addressed currently.

EU Regional Director Epidemiology Michael Busch-Sørensen, Merck Research Laboratories

14.30

Multi-county post authorisation safety and effectiveness studies An increasing number of post authorisation studies are performed using healthcare register data from multiple countries or database networks. Large populations are needed to evaluate the risk of rare events associated with infrequent exposures.

Studies in different populations and healtcare settings also provide useful information on the validity of the results.

• The presentation describes and addresses the legal, logistical, data management and statistical challenges of multi-database studies

Senior Researcher Morten Andersen, Centre for Pharmacoepidemiology, Karolinska Institutet 15.15

Coffee Break

15.35

EXPERT PANEL DISCUSSION on PASS and PAES designs • Secondary use of health data • Use of big data sources in PV - how far are we?

• Data driven pharmacovigilance and elaborate post authorization monitoring of benefit-risk in the market has been conceptualised, but how far are we in the industry?

• Industri perspectives – a hot topic Lawyer, Partner Martin Dræbye Gantzhorn, Horten Senior Consultant Martin Holm-Petersen, Navitas Life Sciences EU Regional Director Epidemiology Michael Busch-Sørensen, Merck Research Laboratories

17.05

Chairman’s closing remarks

17.15

End of Conference

DATES AND CONFERENCE VENUE Pharmacovigilance 2016 will take place on 17th of March 2016 at CPH Conference – DGI-byen, Tietgensgade 65, 1704 København V, Phone: +45 33 29 80 00, www.dgi-byen.dk

ACCOMMODATION Accommodation is not included in the registration fee. Please contact CPH Conference – DGI-byen for room reservation, Phone: +45 33 29 80 70.

VENUE AND REGISTRATION

PARKING DGI Byen has its own parking garage with 192 vehicle spaces. The parking garage is centrally located with entrance from Ingerslevsgade, 1704 Copenhagen V. A one day ticket is 190 DKK. www.dgi-byen.dk/parkering/ Insight Events 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 5 February DKK 8,495

Registration by 4 March DKK 8,995

Registration after 4 March DKK 9,495

If you are more than one from your company, please contact us for an offer.

REGISTRATION FORM

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

Name

REGISTRATION

Job Title Department

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

E-mail Woukd you like to receive information on future events by e-mail?  Yes pleae  No thank you Company Name

CANCELLATION All cancellations must be submitted in writing. All cancellations received by 2 March 2016 are subject to an administrative charge of 10 percent of the registration fee. All cancellations received between 2 March and 14 March 2016 are subject to an administrative charge of 50 percent of the registration fee We regret that cancellations received after 14 March 2016 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.

Insight Events ApS, Silkegade 17, st., Postbox 2023, DK-1012 Copenhagen K, Tel: (+45) 35 25 35 45, info@insightevents.dk, www.insightevents.dk, Giro 3 93 14 55, VAT registered No 24 24 03 71

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 I am attending the conference  I am unable to attend the conference. Please send me the speaker presentations (DKK 2,495 exclusive VAT)

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www.insightevents.dk

Insight Events, Silkegade 17, st., 1113 København K

info@insightevents.dk