There has been contemplation about the optimization of the Support Services and the services of the Administrator General of the FAMHP. This contemplation was partially held to improve the processes, but also to prepare for the move and future cooperation within the framework of the redesign of the health care administration.
There was a decision made to set up a Transversal Support entity that bundles all of the tasks of the entities Services of the administrator-general and Support Service under one entity. In addition, a few service names were changed as well.
MANAGEMENT SUPPORT
MEETINGS
Transparency Committee
Staff Chief Executive Officer’s services (till 15.10.2018 included)
Staff Transversal Support (from 15.10.2018)
QUESTIONS
DATA PROTECTION OFFICER
DEMANDS FOR ADVICE
demands for advice concerning privacy of internal and external collaborators were receivedt
DATA BREACH REPORTS
data breach was reported (this reports did not require being reported to the data protection authority)
OTHER GDPRGeneral Data Protection Regulation RELATED COMPLAINTS
external GDPRGeneral Data Protection Regulation related complaint received
INFORMATION CAMPAGNES GDPRGeneral Data Protection Regulation AND EDUCATIONAL ACTIVITIES
internal GDPRGeneral Data Protection Regulation newsletters
PROJECT & PORTFOLIO MANAGEMENT OFFICE CO-ORDINATION
projects were accepted (100 %)
Duration of the project
ICTInformation and communication technology DIVISION
PROJECTS AND DEVELOPMENT ENTITY
Projects
hours
Maintenance/Support
hours
Administration
hours
Operations entity
Team Service Desk
Time management: top 7
Infrastructure Team
System availability
B&McBudget and Management Control DIVISION
BUDGET AND MANAGEMENT CONTROL
Our organisation as a whole benefits from the tasks of the B&McBudget and Management Control Division, which deal with budget management. The related figures are included under the Budget section.
COMMUNICATION DIVISION
INTERNAL COMMUNICATION
PRESS
EXTERNAL COMMUNICATION
views on our messages on social media
INFORMATION CAMPAIGN
Biological and biosimilars products
With this new campaign, the FAMHPFederal Agency for Medicines and Health Products and the RIZIV-INAMINational Institute of Health and Disability Insurance wish to inform patients about biological medicinal products that broaden the scope of possibilities for treating certain serious and chronic diseases such as diabetes, autoimmune diseases and cancers.
Biological medicinal products are often essential for the treatment of serious and chronic diseases. Using biosimilar alternatives has a positive effect on the accessibility of our health care system.
For more information, visit www.medicamentsbiosimilaires.be/www.biosimilairegeneesmiddelen.be.
LEAFLETS AND POSTERS
ordered by health care professionals, schools, citizens …
leaflets
posters
LEGAL AFFAIRS DIVISION
internal rules
international treaty with the Grand Duchy of Luxembourg
P&OPersonnel and organisation DIVISION
QUALITY DIVISION
IMPROVING POINTS
Follow-up of improving points
QUALITY DOCUMENTS
Number of quality documents approved and implemented
PROCESSES
AUDITS
of which
EXTERNAL COMPLAINTS
Number of complaints received
Complaints about the FAMHPFederal Agency for Medicines and Health Products
Complaints against FAMHPFederal Agency for Medicines and Health Products partners
HUMAN TISSUE MATERIAL COORDINATION
FACILITY UNIT
Survey to identify satisfaction levels with Logistics services
Translation Team
of which
Translations
INTERNATIONAL RELATIONS UNIT
Preparation and feedback of international meetings
Active participation in the TFCIVRHMA-v Task Force on coordination of the Implementation of the Veterinary Regulation
sstudy visit to the FAMHPFederal Agency for Medicines and Health Products:
- Thai delegation – May 2018
- Chinese delegation – June 2018
- Brazilian delegation – June 2018
- Public consultation from the European Commission on pharmaceuticals in the environment
- Questionnaire 04.2018 – annual report of the UNODCUnited Nations Office on Drugs and Crime: ARQ 2017
- Survey 05.2018 – Survey EnprEMA WG – Preparedness in paediatric Clinical Trials_CLINICAL TRIAL FACILITATION GROUP – FAMHPFederal Agency for Medicines and Health Products
- Questionnaire 09.2018 – WHOWolrd Health Organisation – Roadmap on Access to medicines – Good Practices
- Questionnaire 09.2018 – Survey to Member States to map communication and metric practices on shortages and availability of veterinary medicines
- Study 12.2018 – EMAEuropean Medicines Agency Study on Marketing Authorisation Procedures
New
Within the FAMHPFederal Agency for Medicines and Health Products, a Brexit coordinator was appointed who took part in the special Brexit assignment of the DG European Affairs and Coordination within Buza.
The FAMHPFederal Agency for Medicines and Health Products experts took place in the technical seminars of the European Commission on the authority of the FAMHPFederal Agency for Medicines and Health Products.
The administrator general, Xavier De Cuyper, and Bruno Urbain, evaluator and representative of the FAMHPFederal Agency for Medicines and Health Products in the CVMPCommittee for Medicinal Products for Veterinary Use play an active part in the EMAEuropean Medicines Agency Working Groups on Committees’ Operational Preparedness
The administrator general, Xavier De Cuyper is part of the Brexit Task force of the HMAHeads of Medicines Agencies - network of the European competent authorities.
A CULTURE OF CONSULTATION
The FAMHPFederal Agency for Medicines and Health Products attaches great importance to dialogue with all its external partners. The FAMHPFederal Agency for Medicines and Health Products has therefore established various committees, commissions and consultation platforms to provide a structure for and organise its consultation efforts.
You can find additional information on the FAMHPFederal Agency for Medicines and Health Products‘s website, such as the role, composition, rules of procedure, agendas, and reports of these committees, commissions and consultation platforms.
Here, we explain the main activities of the Advisory Committee and the Transparency Committee.
CONSULTATIVE COMMITTEE
The Consultative Committee advises the FAMHPFederal Agency for Medicines and Health Products on the current and future policy. This committee is made up of representatives of patients and consumers from all sectors involved in the matters for which the agency is responsible and of representatives of the federal public services concerned. It is chaired by the Chief Executive Officer of the FAMHPFederal Agency for Medicines and Health Products.
Three meetings were held at which current themes were addressed:
- Interactive website for the coordination of the activities of the ethics committee within the domain of non-medication tests;
- Campaign on clinical trials “2031 needs you!”;
- Implementation of European ordinance regarding clinical trials;
- Implants: traceability, control, evaluation, materiovigilance and transparency;
- Patient Support Programme;
- Unavailability of medicines;
- Royal Decree of 6 September 2017 regarding narcotics and psychotropic substances: prohibition of discount for pharmacists by clarification of FAMHPFederal Agency for Medicines and Health Products scope of applicability;
- Magistral preparation chenodeoxycholic acid for cerebrotendinous xanthomatosis (CTX);
- Action points and possible consequences for Belgium after Brexit.
TRANSPARENCY COMMITTEE
The Transparency Committee is and remains an organ where working with a transparency regarding the stakeholders that contribute to the financing of the agency is key. The chair is Ann Adriaensen (pharma.be). As of 7 November 2018, Koen Straetmans (APB) succeeded Marc-Henry Cornély (Ophaco) as chair.
The Transparency Committee gathered eight times.
The main items of the plenary meeting were:Budget control 2018:
- Budget 2019-2020-2021;
- (Changes to) financing law;
- Operational plan 2018-2019;
- Feedback from the audit committee;
- Brexit;
- Update Redesign;
- Reporting of financial results, operational plan and basic processes.
The committee issued four official opinions. This regarding:
- The proposal for the budget for 2019 and the multi-year frameworks for 2020-2021;
- The determinations regarding the financing of the FAMHPFederal Agency for Medicines and Health Products included in the draft of the law containing various provisions regarding health (7);
- FAMHPFederal Agency for Medicines and Health Products strategic plan 2019-2021.
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