Adapting to the New EU Pharmacovigilance Legislation – A joint DIA/EFGCP Workshop Event #12114 12-13 June 2012 Hilton London Docklands Riverside Hotel, London, UK Programme Co-Chairs Day 1 Christine Bendall Consultant, Director, Pharview Ltd, UK Mick Foy Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), UK Programme Co-Chairs Day 2 Magda Daudin Head of Safety and Pharmacovigilance Inspection, Agence nationale de sécurité du médicament et des produits de santé (ANSM, formerly Afssaps), France Monika Pietrek Managing Director, Pietrek Associates GmbH, Germany Programme Committee Helle Harder Head of Department, Drug Safety, Danish Medicines Agency, Denmark Fergus Sweeney Head of Sector, Compliance and Inspection, European Medicines Agency, EU Lisbeth Tofte Head of Drug Safety Consult, Denmark Representing EFGCP Audit Working Party Margaret Walters Director & Deputy EU QPPV, Merck Sharp & Dohme Ltd., UK Continuing Education DIA meetings and trainings are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available. Overview Following the recent EU Commission consultation on the first wave of the draft GVP guidance and the issue of the second draft of the Implementing Regulation, many questions are still unanswered with respect to the implementation of the new pharmacovigilance (PV) requirements and management of the transition period. The topics range from administrative aspects such as the PV System Master File and quality systems, to other more complex areas which may impact patient safety, such as stakeholders’ responsibilities for signal detection, the revised PSUR and RMP templates and MAH interactions with central and national regulatory bodies. As the date when the new requirements will take effect approaches, there is a pressing need for the available GVP Modules to be finalised and for guidance on how to manage the transition from the current to the new regulatory regime. The new PV legislation is closely linked to the establishment and maintenance of reliable quality management systems, therefore, this workshop will address: 1. How regulatory authorities and industry envisage the implementation of the new requirements, how it will/ should change PV operations in routine and emergency situations? And 2. How compliance will be ensured and assessed and PV inspections undertaken and successfully passed during the transition period? In order to stimulate open discussion and address specific topics in detail, this interactive workshop will utilize a combination of plenary sessions and break-out groups for both days. During the concise plenary session on Day 1, the speakers will address the operational challenges of the key changes arising from the new legislation. This will be followed by practical, focused discussions in break-out groups. Afterwards the groups will reassemble in a plenary session to present summaries of the matters discussed and to present specific recommendations for adapting to and managing the transition. Day 2 will follow the same format as applied on Day 1, however, compliance with the new PV legislation (i.e. handling of inspections and audits) will be the prevailing theme. A number of specific topics related to the transition will be assigned to the break-out groups. During registration attendees will be able to propose hot topics and select their topic of primary interest for group assignment. Please note: The order and selection of topics in this advance notice is based on current information published with respect to implementing texts and guidance and may therefore, be subject to change in line with any further European Commission or European Medicines Agency (EMA) releases on implementation. Who Should Attend This workshop is aimed at intermediate and experienced professionals from: • Regulatory agencies • The pharmaceutical industry and service providers • Academic institutions • Ethics committees including • Pharmacovigilance staff • Qualified Persons for Pharmacovigilance • Quality Assurance personnel for PV and pharmacovigilance inspectors • Regulatory affairs personnel • Other staff members involved in the implementation, project management, IT liaisons Industry representatives from large and small to medium enterprises world-wide, holding or applying for marketing authorisations on pharmaceutical, biological or generic medicinal products in EU, are strongly encouraged to participate in this interactive workshop. Representatives from regulatory agencies working in licensing, pharmacovigilance or quality assurance as well as representatives from regional authorities and ethics committees may also have a particular interest in participation. The number and size of the break-out groups will support lively discussion. Objectives of this workshop • To provide a neutral platform for regulators, industry, academic institutions and ethics committees to review jointly the implementation of the new PV legislation with specific focus on managing the transition • To increase common understanding about compliance monitoring and external assessment of PV compliance during the transition period.
Transcript
Adapting to the New EU Pharmacovigilance Legislation – A joint DIA/EFGCP Workshop
Event #1211412-13 June 2012 Hilton London Docklands Riverside Hotel, London, UK
Programme Co-Chairs Day 1
Christine Bendall Consultant, Director, Pharview Ltd, UK
Mick Foy Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), UK
Programme Co-Chairs Day 2
Magda Daudin Head of Safety and Pharmacovigilance Inspection, Agence nationale de sécurité du médicament et des produits de santé (ANSM, formerly Afssaps), France
Helle HarderHead of Department, Drug Safety, Danish Medicines Agency, Denmark
Fergus Sweeney Head of Sector, Compliance and Inspection, European Medicines Agency, EU
Lisbeth TofteHead of Drug Safety Consult, DenmarkRepresenting EFGCP Audit Working Party
Margaret Walters Director & Deputy EU QPPV, Merck Sharp & Dohme Ltd., UK
Continuing Education
DIA meetings and trainings are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available.
OverviewFollowing the recent EU Commission consultation on the first wave of the draft GVP guidance and the issue of the second draft of the Implementing Regulation, many questions are still unanswered with respect to the implementation of the new pharmacovigilance (PV) requirements and management of the transition period. The topics range from administrative aspects such as the PV System Master File and quality systems, to other more complex areas which may impact patient safety, such as stakeholders’ responsibilities for signal detection, the revised PSUR and RMP templates and MAH interactions with central and national regulatory bodies. As the date when the new requirements will take effect approaches, there is a pressing need for the available GVP Modules to be finalised and for guidance on how to manage the transition from the current to the new regulatory regime.The new PV legislation is closely linked to the establishment and maintenance of reliable quality management systems, therefore, this workshop will address:
1. How regulatory authorities and industry envisage the implementation of the new requirements, how it will/should change PV operations in routine and emergency situations?
And
2. How compliance will be ensured and assessed and PV inspections undertaken and successfully passed during the transition period?
In order to stimulate open discussion and address specific topics in detail, this interactive workshop will utilize a combination of plenary sessions and break-out groups for both days.During the concise plenary session on Day 1, the speakers will address the operational challenges of the key changes arising from the new legislation. This will be followed by practical, focused discussions in break-out groups. Afterwards the groups will reassemble in a plenary session to present summaries of the matters discussed and to present specific recommendations for adapting to and managing the transition.Day 2 will follow the same format as applied on Day 1, however, compliance with the new PV legislation (i.e. handling of inspections and audits) will be the prevailing theme. A number of specific topics related to the transition will be assigned to the break-out groups. During registration attendees will be able to propose hot topics and select their topic of primary interest for group assignment. Please note: The order and selection of topics in this advance notice is based on current information published with respect to implementing texts and guidance and may therefore, be subject to change in line with any further European Commission or European Medicines Agency (EMA) releases on implementation.
Who Should Attend This workshop is aimed at intermediate and experienced professionals from: •Regulatoryagencies•Thepharmaceuticalindustryandserviceproviders•Academicinstitutions•Ethicscommittees
Industry representatives from large and small to medium enterprises world-wide, holding or applying for marketing authorisations on pharmaceutical, biological or generic medicinal products in EU, are strongly encouraged to participate in this interactive workshop. Representatives from regulatory agencies working in licensing, pharmacovigilance or quality assurance as well as representatives from regional authorities and ethics committees may also have a particular interest in participation.
The number and size of the break-out groups will support lively discussion.
Objectives of this workshop•Toprovideaneutralplatformforregulators,industry,academicinstitutionsandethicscommitteestoreview
jointly the implementation of the new PV legislation with specific focus on managing the transition•ToincreasecommonunderstandingaboutcompliancemonitoringandexternalassessmentofPV
compliance during the transition period.
2
TUESDAY I 12 June 201208:00 REGISTRATION AND WELCOME COFFEE
09:00 Session 1
WHAT CHANGES HAVE BEEN INTRODUCED BY THE NEW PV REQUIREMENTS? WHAT IS THE TIMETABLE FOR TRANSITION? Session Co-Chairs: Christine Bendall, Consultant, Director Pharview Ltd, UKMick Foy, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), UK
The session will address the practical changes that stakeholders are in the process of making, or should make to their PV systems in order to be prepared for the coming into effect of the new legislative requirements, from both industry and regulatory authority viewpoints. The transitional provisions in relation to various aspects of the new rules are complex and only part of the series of Good Vigilance Practice (GVP) Guidance Modules will be available in July 2012: the session will seek to identify the major outstanding questions and associated challenges for implementation and application of the new requirements.
Managing the Transition – The transitional provisions and timetable for making the switch from the current to the new requirements in relation to key PV documents and activities Mick Foy, Group Manager, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), UK
The Major Questions and Challenges of Implementation - Viewpoint of a small to medium-sized Marketing Authorisation Holder (MAH) Balwant Heer, EU QPPV, Mylan Ltd, UK
The Major Questions and Challenges of Implementation - Viewpoint of a large MAH Peter De Veene, EU QPPV, Roche Products Ltd, UK Key Elements of GVP Guidance – How to manage key PV activities in the absence of a full set of finalised GVP guidelines Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands
11:00 COFFEE BREAK
11:30 Session 2
PARALLEL BREAK-OUT SESSIONSEach break-out session will discuss a specific topic. A facilitator will lead the discussion and one group member will act as rapporteur. The breakout session will be divided into two parts, one before and one after lunch. Attendees will sign up for one break out session and are kindly asked not to switch between groups. The results of the individual sessions will be presented by each group rapporteur during the second plenary session in the afternoon.
Facilitators: Peter De Veene, EU QPPV, Roche Products Ltd, UKVicki Edwards, Senior Director Pharmacovigilance & EU QPPV, Abbott Laboratories Ltd, UK Helle Harder, Head of Department, Drug Safety, Danish Medicines Agency, DenmarkBalwant Heer, EU QPPV, Mylan Ltd, UK Monika Pietrek, Managing Director, Pietrek Associates GmbH, GermanyLisbeth Tofte, Head of Drug Safety Consult, Denmark, Representing EFGCP Audit Working PartyMargaret Walters, Director & Deputy EU QPPV, Merck Sharp & Dohme Ltd, UK
Registrants will have the opportunity to choose between one of the following six topics when registering for the workshop. The final selection of topics will be determined two weeks prior to the workshop which may affect individual preferences.
Topics 1 – 6, with particular reference to the transitional period between 2012 and 2015:
• Adapting the MAH PV system: the PV SMF, reviewing MAHstructure and organization, identifying resources, reviewing roles and responsibilities (including QPPV), managing and retaining documentation, and training
collection and collation of non-serious and non-HCP reports, handling other relevant safety information
• New reporting and submission requirements: reporting issuesarising from the state of readiness of EudraVigilance, ADR reporting timelines, and submission of PSURs
• RiskManagementPlans:systemssummaries,writingandrevisionofRMPs, meeting and monitoring conditions of MA grant
• Post-Authorisation Safety and Efficacy Studies (PASS / PAES):introducing processes for the new requirements; the distinction between imposed and voluntary studies.
12:30 LUNCH BREAK
13:30 Session 2
PARALLEL BREAK-OUT SESSIONS CONTINUEDFacilitators: see above
14:30 COFFEE BREAK
15:00 Session 3
FINDINGS / REPORTING OF BREAK-OUT GROUPSSession Co-Chairs: Christine Bendall, Consultant, Director Pharview Ltd, UKMick Foy, Group Manager, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), UK Each rapporteur will present a summary of their group’s major points andconclusions/recommendations.
16:00 Session 4
PANEL DISCUSSION Session Co-Chairs: Christine Bendall, Consultant, Director Pharview Ltd, UKMick Foy, Group Manager, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), UK
The Programme Committee, speakers and facilitators will join the panel. The discussion will be open to the participation of the entire audience.
17:00 DRINKS RECEPTION
18:00 END OF DAY ONE
WEDNESDAY I 13 June 2012
08:00 REGISTRATION AND WELCOME COFFEE
09:00 Session 1
HOW CAN A MAH ENSURE COMPLIANCE DURING THE TRANSITION? WHAT DO PV INSPECTORS EXPECT?HOW CAN A MAH SUCCESSFULLY PASS INSPECTIONS DURING THE TRANSITION? Session Co-Chairs: Monika Pietrek, Managing Director & Senior Consultant, Pietrek Associates GmbH, GermanyMagda Daudin, Head of Safety and Pharmacovigilance Inspection Unit, ANSM, France With the new legislation coming into effect in July 2012, regulatory agencies and marketing authorization holders are getting prepared for the new processes. Depending on the status of the individual marketing authorisation, companies are facing various operational challenges regarding the adaptation, as the release of the detailed guidance will continue to occur throughout the rest of 2012. In addition, the 3 year transition period will require substantial increased efforts due to parallel work flows and enhanced required skill set. The following presentations will reflect different view points from members of regulatory agencies and industry.
Unless otherwise disclosed, DIA Europe acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of the DIA Europe.
Speakers and agenda are subject to change without notice. RecordingofanyDIAEuropetutorial/workshopinformationinanytypeofmedia, is prohibited without prior written consent from DIA Europe.
3
EU PhV IWG: Key role in ensuring a harmonised approach to supervision of PV compliance by MAHs Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU
An Inspector’s View of Regulatory Expectations post-July 2012 –“Don’t panic” Manjit Virdee, Senior Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), UK Handling the Transition for PV Compliance – An industry perspectiveNoha Kassem, Senior Director, Global Patient Safety, Eli Lilly Ltd, UK Handling Safety in PASS, Marketing Initiatives etc. – What structure is needed; how wide are the obligations and does it ever stop!Lisbeth Tofte, Head of Drug Safety Consult, Denmark, Representing EFGCP Audit Working Party
11:00 COFFEE BREAK
11:30 Session 2
PARALLEL BREAK-OUT SESSIONSEachbreak-out sessionworkona specific topic. One facilitatorwilllead the discussion and one group member will act as the rapporteur. The break-out session consists of two parts, one before, one after lunch. Attendees will sign up for one break-out session and are kindly asked not to switch between groups. The results of the individual break-out session will be presented by each rapporteur during a second plenary session in the afternoon.
Facilitators: Christine Bendall, Consultant, Director Pharview Ltd, UKMagda Daudin, Head of Safety and Pharmacovigilance Inspection, ANSM, FranceVicki Edwards, Senior Director & EU QPPV, Abbott Laboratories Ltd, UK Suvi Loikkanen,SeniorPharmaceuticalOfficer,DrugSafetyandDrugInformation Department, National Agency for Medicines, FinlandMonika Pietrek, Managing Director, Pietrek Associates GmbH, GermanyLisbeth Tofte, Head of Drug Safety Consult, Denmark, Representing EFGCP Audit Working PartyMargaret Walters, Director & Deputy QPPV, Merck Sharp & Dohme Ltd, UK
Registrants have the opportunity to choose between one of the following seven topics when registering for the workshop. The final selection of topics will be determined two weeks prior to the workshop which may affect individual preferences
Topics 1 – 7:• Safety Governance within individual companies and in business
partner relationships• Safety & compliance monitoring in PASS, marketing initiatives,
patient support programmes, compassionate use, social media• Compliancerelatedtoglobalperiodicsafetyreports,inparticularin
versus Competent Authority (CA) in signal detection• Compliance in reporting of non-serious Individual Case Safety
Reports (ICSRs) from post-authorisation safety studies (PASS) • Responding to inspection findings - successful management ofcorrectiveaction/preventiveaction(CAPA)
• Review of Quality Systems – resources, record handling and selfaudit
12:30 LUNCH BREAK
13:30 Session 2
PARALLEL BREAK-OUT SESSIONS CONTINUED Facilitators: see above
14:30 COFFEE BREAK
15:00 Session 3
FINDINGS / REPORTING OF BREAK-OUT GROUPSSession Co-Chairs: Monika Pietrek, Managing Director, Pietrek Associates GmbH, GermanyMagda Daudin, Head of Safety and Pharmacovigilance Inspection Unit, ANSM, France Each rapporteur will present a summary of their group’s major points andconclusions/recommendations.
16:00 Session 4
PANEL DISCUSSION Session Co-Chairs: Monika Pietrek, Managing Director, Pietrek Associates GmbH, GermanyMagda Daudin, Head of Safety and Pharmacovigilance Inspection Unit, ANSM, France
The programme committee, speakers and facilitators of the breakout sessions will join the panel. The discussion will be open to the entire audience participation.
17:00 END OF WORKSHOP
For more information please contact [email protected], or call +41 61 225 51 78
TRAVEL INFORMATION
London Gatwick Airport / Stansted Airport
Please use this link to get directions to the Hilton London Docklands Riverside Hotel: http://www1.hilton.com/en_US/hi/hotel/LONNDHI-Hilton-London-Docklands-Riverside/directions.do#localairports
London City Airport
Take the DLR train to Bank DLR Station, change platform at Poplar DLR Station towards Lewisham DLR Station or change to the Underground Jubilee Line towards Stanmore at Canning Town. Leave at Canary Wharf Station and walk to the Canary Wharf Pier. Take the complimentary ferry service (for hotel guests only) to cross the river Thames to arrive at the Hilton London Docklands Riverside Hotel.
The hotel is no longer allowed to operate the courtesy bus service to Canada Water. If you wish to use Canada Water Station, please use the C10 public bus service that stops outside the hotel. The stop is displayed and announced as the Hilton London Docklands Riverside.
For more details please visit: www.tfl.gov.uk
HOTEL INFORMATIONThe DIA has blocked a number of rooms at the:
Hilton London Docklands Riverside Hotel265 Rotherhithe Street London SE16 5HW, UKhttp://www1.hilton.com/en_US/hi/hotel/LONNDHI-Hilton-London-Docklands-Riverside/index.do
at the special rate of:£ 139.00 for room and breakfast, exclusive of VAT
Group Name: Drug Information Association Group Code: GDIAC
To make your reservation please use this link:http://www.hilton.com/en/hi/groups/personalized/L/LONNDHI-GDIAC-20120611/index.jhtml?WT.mc_id=POG
Orcallthereservationteam:+44(0)2072311001
Important: Please complete your reservations by 31 May 2012 at the latest. Reservations received after this date will be subject to hotel availability and room rate may vary.
In case of cancellation:Cancellationofthehotelbookingmustbemadeinwritingdirectlytothehotel48hourspriortothearrivaldate.Cancellationsmadeatleast48hourspriortoarrivalwillnot incuranycancellationcharges.Anycancellationmade less than48hoursprior to arrival will be subject to the first night being charged at the full agreed rate. All no shows will be billed for the entire stay.
11105DIAWEB
ID # 12114REGISTRATION FORMAdapting to the new EU Pharmacovigilance Legislation 12-13 June 2012 | Hilton London Docklands Riverside Hotel, London, UK
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