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Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 1
Session 1 - View from European Medicines Regulatory Network Prof. Karl Broich
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 2
EU Medicines Network & Strategy to 2020 • HMA network: > 50 national competent authorities from EU/EEA - close
cooperation - complementary approaches - common mission:
− securing efficient and effective operation of both the European Medicines
Regulatory System and the Network
− ensuring that available resources are sufficient to support the work of the
network
− ensuring that the Network is aware of and responds appropriately to the
challenges it faces due to the ever-changing nature of the environment in
which it operates
• Close cooperation between EMA and HMA - common strategy to 2020
outlining
− common challenges and opportunities
− setting out joint key priorities & a high-level roadmap to achieve these
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 3
HMA - Multi Annual Work Plan (MAWP)
• After finalisation of the joint HMA/EMA strategy, the HMA
developed a MAWP to bring the joint overarching strategy into
operation on the HMA level with the involvement of all NCAs. • 11 Priorities, e.g. Innovation & access to new medicines,
Availability of good quality appropriately authorized medicines,
Responding to public and animal health emergencies,
Competence development programme,…
• Mid-term review 2018
• Discussion started for building up common strategy to 2025
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 4
Challenges and opportunities for the EU Medicines network
Big Data, Real World, eHealth...
Complex Lifecycle Management
Changes to the current health care system
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 5
Preclinical Phase
Complex Lifecycle-Management
Phase II/III/Market Access Phase I/II
GT R
T PK
SAD/MAD/Food (DD)/POC
RP
RT GT
Pivotal 2 / Added Value
RT
Phase 0
Exp 1
Exp 2
Adaptive Pathway
Dose finding / Pivotal
SA
SA
SA
SA
PRIME
Portfolio-Meetings
Pivotal 3 / Added Value 2
RMP/PASS
BfArM + HTA (G-BA)
Pivotal 4/ Added Value 3
BfArM + HTA (G-BA)
BfArM + HTA (G-BA)
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 6
2 - Increasing complexity in the health care system
Digitalisation Real World Data/
„Big Data“
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Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 7
Ongoing Ideas in the European Network
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 8
Structure of Research and Cooperations at the BfArM
Pharmacogenetics
Personalized Medicine
Pharmaco-epidemiology
Medical Devices Safety
Universität Bonn Centre for Translational Medicine
Licensing
Pharmacovigilance
Medical Devices/ Borderline Products/
eHealth
Ad Hoc Research
Areas
Research Department
Trainee
Programmes Advanced Training, Scientific
Symposiums
Integration
DZIF
DZNE
Key Research Areas Regulation
Internal Research Council
Scientific Advisory Board
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 9
Center for Translational Medicine (CTM) Partnership of Research Facilities
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 10
Regulatory Sciences: Which Data for What?
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 11
Research
Particular challenges in translational medicine
Marketing Authorization
Therapy
X
• Very early education, communication and cooperation • Identify key elements, systematic service and advice
Shapen the chain
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 12
• BfArM - as well as the entire EU regulatory network - supports Regulatory Sience by offering interaction, communication, education & advice as early as possible
• The impact of systematic approaches must be analyzed to allow further
optimization • Regulatory environments are changing experiences are to be shared mechanisms and incentives to promote Regulatory Science
(and keep it up-to-date) must be continuously adapted to future developments
Conclusions
Prof. Karl Broich | Session 1- Responding to the needs of the 21st century Patient | 30 October 2018 | Page 13
Contact Federal Institute for Drugs and Medical Devices Prof. Dr. Karl Broich President Kurt-Georg-Kiesinger-Allee 3 D-53175 Bonn [email protected] www.bfarm.de Tel. +49 (0)228 99 307-3219
Thank you very much for your attention!