Bringing real-life experience into the evaluation of medicines EMA interaction with healthcare professionals Presented by Ivana Silva on 19 April 2016 An agency of the European Union Patients and Healthcare Professionals Department / Stakeholders and Communication Division
Why do To make sure that we need the decisions we take to talk to are meaningful When for your practice each and have a and positive impact other How on your patients 1
The various roles of the EMA The Agency is responsible for: • The evaluation of marketing authorisation for human and veterinary applications submitted by pharmaceutical companies • The coordination of European pharmacovigilance (supervision of the medicines on the market) • The provision of scientific advice on the development of medicines • The evaluation of applications for orphan designation in EU • The evaluation of paediatric investigation plans (or waivers) • The evaluation of arbitration and referral procedures • The provision of good quality and independent information on the medicines it evaluates to patients and healthcare professionals • The coordination of Member States’ inspections (GMP, GCP, GLP) 2
Medicines Where do the regulatory and clinical contexts information come together? Risk management and communication Benefits/risks balance 3
Approved via EMA Safety reviews involving nationally (centralised procedure) authorised medicines Dabigatran Cangrelor (EMA level) Rivaroxaban Canagliflozin Bivalirudin Loxapine Valproate Outcomes of Aripiprazole Paliperidone Codeine periodic safety Imatinib Lurasidone Domperidone update report single Sunitinib Olanzapine Diclofenac assessments Insulin degludec Duloxetine Tetrazepam Pioglitazone Orlistat hydrochloride 4
European Regulatory Network The European regulatory system for medicines is a unique model in the global regulatory environment. National Patients and Agencies Consumers EMA Scientific Committees Learned Healthcare societies professionals Academia and Networks 5
Collaboration of EMA with healthcare professionals Ongoing… 2014 Systematic 2013 inclusion of clinical Dedicated Patients practice input into and Healthcare 2011 Healthcare EMA regulatory Professionals Professionals output Department Working Party Framework of created (HCPWP)created interaction with 2006 Healthcare Professionals First workshop with • Healthcare 1995 Professionals organisations EMA created Working group with • Healthcare Professionals created 6
Framework for interaction between the EMA and healthcare professionals Support the Agency in order Contribute to a more efficient to access the best possible Enhance healthcare professional and targeted communication independent expertise organisations’ understanding to healthcare professionals, and obtain information on the of the role of the EU medicines to support their role in the safe current use of medicines in Regulatory Network and rational use of medicines real clinical practice Network of European healthcare professional organisations 7
Maintenance of the Network of European healthcare professional organisations (HCPOs) • Transition into revised eligibility criteria • 29 eligible organisations by Dec 2015 8
Healthcare Professionals Working Party (HCPWP) Platform for dialogue and exchange on relevant issues concerning medicines; The HCPWP provides recommendations to the EMA and its Human Scientific Committees on all matters of direct or indirect interest to healthcare professionals 9
Involvement in core activities * 15 cases of interaction with GPs *WP – working parties 10
Sustained involvement in core activities SAG – Scientific Advisory • Group SC – Scientific Committee • WP – Working Party • DHPC – Direct healthcare • professional communication SA – Scientific Advice • • Input and participation continues to be spread-out by various core activities • Cases of interaction with previous years differ, due to the nature of the Agency’s activities 11
Opportunities for Healthcare Professional involvement along the medicine lifecycle at EMA HCP input Product information Safety Product information HCP Communications input & DHPC POST PRE-SUBMISSION EVALUATION AUTHORISATION Paediatric Scientific Advice Marketing Authorisation Post Marketing Orphan designation/ Investigation ATMP classification Protocol assistance Application Evaluation Authorisation Plan CHMP CAT CHMP- CHMP COMP PDCO PRAC SAWP PRAC HCP HCP HCP HCP COMP input input input input CAT SAG SAG HCP HCP HCP input input input 12
Safety monitoring Research & Development – Risk management Plan – Periodic Safety Update – Spontaneous report Real-life data e-health records? e.g. post- authorisation safety study Clinical trials or collection of safety data data in subpopulation Non-clinical and Scientific clinical safety or drug literature investigations interaction 13
EMA sources of information for HCPs, patients and the general public EPAR summary Assessment Report European Public Summary of Product Characteristics (SmPC) (EPAR) Package Leaflet (PL) Labelling Public Assessment Report(s) PRE-SUBMISSION EVALUATION POST AUTHORISATION MARKETING AUTHORISATION Paediatric Orphan Designation/ Scientific Advice Marketing Authorisation Safety updates/reviews Investigation ATMP Classification Protocol assistance Renewals Application Evaluation Plan Major post-authorisation changes (e.g. new indication) At time of Opinion Press releases Additional EMA product-specific on new Summaries of Summaries of Safety communications publications medicines orphan paediatric (including communications on medication errors) designations investigation plans Summaries of Information on shortages of medicines Opinion (limited to cases assessed by EMA, following manufacturing difficulties or problems affecting the Withdrawals quality of medicines) and refusals Q&As resources Other EMA Newsletter ‘Human medicines highlights’ New product information wording: extracts from PRAC recommendations on signals Opinions on safety variations/PSURs EU-EMA public European database of suspected databases adverse drug reaction reports EU Clinical Trials Register Clinical data publication website
Medicines Where do the regulatory and clinical contexts information come together? Risk management and communication Benefits/risks balance 15
Thank you for your attention Further information [Insert relevant information sources or contact details as applicable.] European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Follow us on @EMA_News
Recommend
More recommend
