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Parole d’expertMatériaux médicaux implantables :le point aujourd’huiChristian GRANDFILS, ULg-CEIB,Vanessa BINAME, DG Post ...
Avec le soutien de :
Federal agency for medicines and health               products  Medical devices – New Belgian Landscape     Plan of our Pu...
FAMHP - Presentation       Legal context       §  The law establishing the creation and the functioning           of the ...
Mission  “Ensuring, from development to use, the quality, safety   and efficacy:          §  of medicines for human and v...
‘Stakeholders’	  or	  partners                                                Industry                                    ...
Organisation   chartSubject                           Datefamhp/entity/Division-Unit-Cell                                 ...
Medical devices              New Belgian Landscape           Plan of our Public Health                    MinisterSubject ...
Why a plan?Medical Devices•  Essential for the health sector•  Source of innovation•  Improve the quality of lifeØ  Bette...
Structure of the plan                                  8 strategic axesSubject                                            ...
TraceabilityObjectives•  Full traceability from the manufacturer to the   patient for each medical device implanted•  Able...
Traceability"   Better knowledge of what is on the Belgian market"   Better knowledge of what is in the patient"   Better ...
Traceability - Representation                                                  Data on                                    ...
Traceability•  Participation of all the actors concerned•  Simple, friendly, should not be an additional   burden for     ...
TraceabilityIdentification ofØ  Implantable medical devices (authentic source / famhp)Ø  Distributors of implantable med...
TraceabilityRegistrationØ  Data on implantable of medical devicesØ  Movements from the final distributor to the patient ...
TraceabilityNew rules•  Implantable on « pres/post »cription (document   from a doctor for a specific patient)•  Distribut...
Traceability•  Integration in eHealth plateform•  Data exchange from system to system•  Generation of a patient’s informat...
How can regulators, industry and health careproviders work together on this•  Should be a win/win situation for everyone• ...
ControlDistributors•        Each belgian distributor will be inspected once every 5         years•        Start with the d...
ControlPublicity and information to patient (or health  professional)•  Clear rules for medical devices advertisement and ...
Control•  Fraud        "   false CE mark,        "   medical devices on our market without CE mark•  Clinical trials      ...
Control•  Efficiency of control        "   Check list        "   Standardisation and simplification of the report        "...
Control•  Information of all the actors•  Rapid and direct sanctionsSubject                            Datefamhp/entity/Di...
ControlRedevance"   Every distributors has to participate to the    regulation of the medical device landscape"   Benefit ...
Evaluation•  Enlargement of the expertise inside famhp•  Better view on clinical trial•  Link with materiovigilance and FU...
Evaluation - European Expert Group   In the recast chapter VIII:   •       Establishment of an expert committee           ...
Evaluation - European Expert Group   Tasks MDCG   1.  Contribution to the assessment of notified bodies   2.  Contribution...
Evaluation - European Expert Group   In discussion (recast)   1.       Extension of the responsibility of the EMA to      ...
Evaluation – Notified bodies   Strenghtening of assessments and controls of      notified bodies   •       Stricter and de...
Materiovigilance•        Contact points network                Materiovigilance         for hospitals                     ...
MateriovigilanceObjectives of the contact points•  Better orientation of all messages related to   materiovigilance•  More...
Materiovigilance•  Standard (european) procedures for evaluation and   notification of risks / incidents•  Sensibilisation...
Other axesTransparency•  Involvement of patient representatives•  Discussion about the publicity rulesMonitoring•  Steerin...
Other axesLegislation•  New law and royal decreeAdmnistrative simplification•  One stop = famhp   ⇒ Transfert of competenc...
Thank you!!!Subject                                          Datefamhp/entity/Division-Unit-Cell                          ...
Contact    Federal agency for medicines and health products - famhp                                     Place Victor Horta...
Your medicines and health products,           our concern
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Matériaux médicaux implantables : le point aujourd’hui par Vanessa Binamé | Liege Creative, 19.03.13

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Le scandale liés aux implants PIP en France fin 2011 a permis de mettre en lumière un ensemble de faiblesses liées au contrôle et au suivi des implants. Depuis lors, de nombreux efforts ont été réalisés tant à l’échelle européenne qu’au niveau belge pour adapter la législation en la matière, mais aussi pour dégager des moyens financiers importants pour en faciliter la mise en place.
A la suite de la table-ronde LIEGE CREATIVE organisée en mars 2012 sur ce même sujet, cette nouvelle réunion permettra de faire l’état des lieux sur ces changements en écoutant des acteurs-clés du secteur : représentants de l'Agence Fédérale des Médicaments et des Produits de Santé, industriels, cliniciens et chercheurs.

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Matériaux médicaux implantables : le point aujourd’hui par Vanessa Binamé | Liege Creative, 19.03.13

  1. 1. Parole d’expertMatériaux médicaux implantables :le point aujourd’huiChristian GRANDFILS, ULg-CEIB,Vanessa BINAME, DG Post | AFMPS,Françoise SCHLEMMER, Quasys Consult,Henri DECLOUX, MEDI-LINE
  2. 2. Avec le soutien de :
  3. 3. Federal agency for medicines and health products Medical devices – New Belgian Landscape Plan of our Public Health Minister Vanessa Binamé
  4. 4. FAMHP - Presentation Legal context §  The law establishing the creation and the functioning of the Federal Agency for Medicines and Health Products of July 20 2006 (B.O.J. 08.09.2006) §  The Law on the medicinal products of 25.03.1964 (B.O.J. 17.04.1964) - revised dd. 01.05.2006 (B.O.J. 16.05.2006) and its implementing decrees The FAMHP is a public interest organization with juridical personality, classified in category A referred in the law of March 16 1954 relating to the control of certain public interest organizationsSubject Datefamhp/entity/Division-Unit-Cell 2
  5. 5. Mission “Ensuring, from development to use, the quality, safety and efficacy: §  of medicines for human and veterinary use, including homeopathic medicines and herbal medicines, pharmacy made and officinal preparations; §  of health products including medical devices and accessories, and raw materials (active pharmaceutical ingredients) for the preparation and production of medicines. Ensuring, from collection to use, the quality, safety and efficacy: §  of all operations involving blood, cells and tissues, which are also defined as health products”.* * Based on the law of 20 July 2006 (B.S. - M.B. 08/09/2006) concerning the establishment and functioning of the FAMHP.Subject Datefamhp/entity/Division-Unit-Cell 3
  6. 6. ‘Stakeholders’  or  partners Industry University and Healthcare Research Centers professionals Patients Policy makers Policy makers (UE institutions (Member States) Competent authorities (Administrations)Subject Datefamhp/entity/Division-Unit-Cell 4
  7. 7. Organisation chartSubject Datefamhp/entity/Division-Unit-Cell 5
  8. 8. Medical devices New Belgian Landscape Plan of our Public Health MinisterSubject Datefamhp/entity/Division-Unit-Cell 6
  9. 9. Why a plan?Medical Devices•  Essential for the health sector•  Source of innovation•  Improve the quality of lifeØ  Better traceability, evaluation and control will increase the quality and safety of medical devicesØ  A clear legal framework with direct sanctions will eliminate the crooks, smugglers and the ignorantsØ  ⇒ A scandal like the PIP should never happend again!Subject Datefamhp/entity/Division-Unit-Cell 7
  10. 10. Structure of the plan 8 strategic axesSubject Datefamhp/entity/Division-Unit-Cell 8
  11. 11. TraceabilityObjectives•  Full traceability from the manufacturer to the patient for each medical device implanted•  Able to know at every moment where a specific device is•  Opportunity for the patient to consult which medical device was implanted to him Subject Date famhp/entity/Division-Unit-Cell 9
  12. 12. Traceability"   Better knowledge of what is on the Belgian market"   Better knowledge of what is in the patient"   Better information of the patient"   Better capacity of control⇒ Short time and specific reaction in case of incident Subject Date famhp/entity/Division-Unit-Cell 10
  13. 13. Traceability - Representation Data on request Distribution / ImplantationManufacturer Intermediate Distributors Information Distributors exchange Pharmacy (Hospital / Retail) Health Professionals PatientCentral RegistrationSubject Datefamhp/entity/Division-Unit-Cell 11
  14. 14. Traceability•  Participation of all the actors concerned•  Simple, friendly, should not be an additional burden for §  Industry §  Health professionals §  Authorities⇒ Focus on the essential Subject Date famhp/entity/Division-Unit-Cell 12
  15. 15. TraceabilityIdentification ofØ  Implantable medical devices (authentic source / famhp)Ø  Distributors of implantable medical devices (authentic source / famhp)Ø  Pharmacies (authentic source / FPS Public Health, INAMI, famhp)Ø  Health professionals (authentic source / FPS Public Health)Ø  Patients (entirely coded) Subject Date famhp/entity/Division-Unit-Cell 13
  16. 16. TraceabilityRegistrationØ  Data on implantable of medical devicesØ  Movements from the final distributor to the patient Subject Date famhp/entity/Division-Unit-Cell 14
  17. 17. TraceabilityNew rules•  Implantable on « pres/post »cription (document from a doctor for a specific patient)•  Distribution via pharmacy ⇒ strenghtening of the role of the pharmacist•  Notification of the use of an implant•  use of implantable medical devices only if already registred in the traceability system Subject Date famhp/entity/Division-Unit-Cell 15
  18. 18. Traceability•  Integration in eHealth plateform•  Data exchange from system to system•  Generation of a patient’s information carte•  Use international standardisation and national conversion tables when really needed•  Exchange data with Eudamed II / III•  Respectful for the private life of implanted patients Subject Date famhp/entity/Division-Unit-Cell 16
  19. 19. How can regulators, industry and health careproviders work together on this•  Should be a win/win situation for everyone•  Communication – Concertation - Step by step approach•  Development of interfaces system to system•  Let all the doors open and pay attention to the SMEs•  Take into account the advanced states of technological development (eg UDI, Combined Products, Combination Packages,…) Subject Date famhp/entity/Division-Unit-Cell 17
  20. 20. ControlDistributors•  Each belgian distributor will be inspected once every 5 years•  Start with the distributors of implantsThematic controls•  Control focused on specific points (materiovigilance conformity, notification obligation, europeese issue, border line products,…)•  Re-Testing on medical devices (risk based analysis, cost, availabilities of laboratory) Subject Date famhp/entity/Division-Unit-Cell 18
  21. 21. ControlPublicity and information to patient (or health professional)•  Clear rules for medical devices advertisement and information•  Methodology of control for publicity and information Subject Date famhp/entity/Division-Unit-Cell 19
  22. 22. Control•  Fraud "   false CE mark, "   medical devices on our market without CE mark•  Clinical trials "   GCP, "   notification to the afmps, "   Deviation from the protocol Subject Date famhp/entity/Division-Unit-Cell 20
  23. 23. Control•  Efficiency of control "   Check list "   Standardisation and simplification of the report "   Administrative support "   Progressive and continue training of inspectors in the medical devices area "   Autocontrol Subject Date famhp/entity/Division-Unit-Cell 21
  24. 24. Control•  Information of all the actors•  Rapid and direct sanctionsSubject Datefamhp/entity/Division-Unit-Cell 22
  25. 25. ControlRedevance"   Every distributors has to participate to the regulation of the medical device landscape"   Benefit for everyone: the patient and the sector Subject Date famhp/entity/Division-Unit-Cell 23
  26. 26. Evaluation•  Enlargement of the expertise inside famhp•  Better view on clinical trial•  Link with materiovigilance and FU of clinical trials•  Collaboration with ethic committees•  Check of the capacity for clinical evaluation for the notified bodies and peer review for high risk MD Subject Date famhp/entity/Division-Unit-Cell 24
  27. 27. Evaluation - European Expert Group In the recast chapter VIII: •  Establishment of an expert committee (Medical Device Coordination Group - MDCG) •  Members appointed by the Member States Benefice risk evaluation >< safety and performance?Subject Datefamhp/entity/Division-Unit-Cell 25
  28. 28. Evaluation - European Expert Group Tasks MDCG 1.  Contribution to the assessment of notified bodies 2.  Contribution to the assessment of higher risk medical devices 3.  Development of guidance 4.  Coordination in the fields of clinical investigations, vigilance and market surveillance 5.  To provide advices to the CommissionSubject Datefamhp/entity/Division-Unit-Cell 26
  29. 29. Evaluation - European Expert Group In discussion (recast) 1.  Extension of the responsibility of the EMA to medical devices and creation of a Medical Device Expert Group at this agency; 2.  Creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency; 3.  Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution; 4.  Creation of a Medical Device Expert Group managed by Member StatesSubject Datefamhp/entity/Division-Unit-Cell 27
  30. 30. Evaluation – Notified bodies Strenghtening of assessments and controls of notified bodies •  Stricter and detailed requirements to be met by Notified Bodies – Recast Annex VI •  In regular intervals, monitoring of Notified Bodies including ‘joint assessments’ (experts from other MS and EC)Subject Datefamhp/entity/Division-Unit-Cell 28
  31. 31. Materiovigilance•  Contact points network Materiovigilance for hospitals FAMHP•  Contact points network for companies CP CP Materiovigilance network Distributors Hospital Subject Date famhp/entity/Division-Unit-Cell 29
  32. 32. MateriovigilanceObjectives of the contact points•  Better orientation of all messages related to materiovigilance•  More specificity•  Direct to the right person•  Privileged interlocutor with the authority Subject Date famhp/entity/Division-Unit-Cell 30
  33. 33. Materiovigilance•  Standard (european) procedures for evaluation and notification of risks / incidents•  Sensibilisation of the actors•  Optimalisation of the assessment of incident Subject Date famhp/entity/Division-Unit-Cell 31
  34. 34. Other axesTransparency•  Involvement of patient representatives•  Discussion about the publicity rulesMonitoring•  Steering committee•  Check the implementation for each action included in the plan•  FU of the working groupsSubject Datefamhp/entity/Division-Unit-Cell 32
  35. 35. Other axesLegislation•  New law and royal decreeAdmnistrative simplification•  One stop = famhp ⇒ Transfert of competencies from Economic affairs and ISP to famhpSubject Datefamhp/entity/Division-Unit-Cell 33
  36. 36. Thank you!!!Subject Datefamhp/entity/Division-Unit-Cell 34
  37. 37. Contact Federal agency for medicines and health products - famhp Place Victor Horta 40/40 1060 Bruxelles tel. 0032 2 524 80 00 fax 0032 2 524 80 01 e-mail welcome@fagg-afmps.be www.afmps.beSubject Datefamhp/entity/Division-Unit-Cell 35
  38. 38. Your medicines and health products, our concern

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