Expertise & support

  1. Showing 50 results for:
  2. Expertise & support
All Regions

Clinical Outcome Assessments support services

Provided by Mapi Trust

MAPI trust

Mapi Research Trust’s PROVIDE services are a unique resource for the scientific community. This full-range support is critical for anyone involved in the field of Clinical Outcomes Assessments (COAs).
PROVIDE, which is available on an ad-hoc basis or within the context of annual subscriptions, includes the following in-house easily accessible services (non-exhaustive list):

Copyright for measures (who owns the measure)
Available translated versions & methodology to translate
Translation Certificates
Providing of scoring manuals
Licensing process / permission to use measures
Find measures in a specific therapeutic indication/on-going clinical trials
Original and review copies of thousands of COAs and translations
List of COA concepts
List of recommended COAs from guidelines
PRO Claims: a study of competitor products and COA Labeling claims
Provide reports that come from PROQOLID / PROLabels
Developer contact (for conditions of use, scoring, translation, etc.)
Bibliographic references
See content validity documentation, availability, psychometric properties, etc.

Visit website

Mechanism of Coordinated Access to orphan medicinal products (MoCA)

Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION

Eurordis

* Mechanism of Coordinated Access to orphan medicinal products (MoCA): is a platform where companies’ issues around reimbursement or financing schemes can be discussed with a variety of jurisdictions and societal perspectives. It provides a mechanism for European countries to collaborate on coordinated access to orphan medicines in a voluntary, dialogue-based approach, intended to create a fluid set of interactions between key stakeholders, across all aspects of a product.

Visit website

Training on translational medicine for patient advocates

Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION

Eurordis

*The EURORDIS Open Academy brings together all EURORDIS trainings with the goal of building the capacity of rare disease patient advocates.
Through the EURORDIS Open Academy capacity-building programmes, EURORDIS empowers patient advocates to have the confidence and knowledge needed to bring their expertise to discussions on health care, research and medicines development.

Visit website

Services to patients

Provided by EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION

Eurordis

EURORDIS promotes the implementation of services adapted to the needs of people living with a rare disease and provides:
* Connect with a patient organisation
* Rare disease helplines: offer social, psychological and information solutions to people living with a rare disease.Specialised Social Services are instrumental to the empowerment of people living with rare diseases and essential to the improvement of their well-being and health.
* Find a specialised Social Service
* Medical expertise

Visit website

Quality management in clinical trials

Provided by CCRI (Children's Cancer Research Institute)

ZANDR

* Quality Management (support)
The QM always works in close cooperation with all staff members to provide cellular therapeutic agents, tissues, diagnostic services and study results of the highest quality and in compliance with legal requirements, guidelines and standards. This includes – but is not restricted to – support in the following respects:
Document management (writing, approval, distribution, version control, archiving, …)
Process management (recording of process flow diagrams, assignment of responsibilities, monitoring of process indicators, process enhancement, …)
Training and further education (conduct, management and refreshment of training)
Risk assessment and performance of risk analyses
Fault and deviation management (classification, allocation, processing and closing of errors, performance of root cause analyses and implementation of improvements)
Complaint handling
Supplier qualification (obtaining certificates or quality questionnaires, approval or blocking of suppliers, …)
Approval of maintenance, calibration and qualification reports for critical equipment
Method and process validation (defining and writing validation plans, calculating and representing results, writing validation reports, …)
Recording and reporting of side effects (pharmacovigilance, tissue vigilance, medical device vigilance)
Implementation of new standards
Auditing and monitoring including their reporting
Annual reporting (product quality reports, vigilance reports, management reports, and others)

Visit website

Joint Clinical Assessment (JCA) and Scientific Consultations (JSC)

Provided by European Network for Health Technology Assessment (EUNetHTA)

EUNETHTA

EUnetHTA develops several services that help inform the decision-making process around the introduction of pharmaceuticals and other technologies at the national, regional and European levels. These include Joint assessments, early diologues and Post Launch Evidence Generation (PLEG)
* Assessment submission: Health technology companies are encouraged to contact us via the following two channels if interested in a EUnetHTA assessment of their product. These are distinguished by EUnetHTA as Pharmaceuticals and Other Technologies (i.e. non-pharmaceuticals).
*Early dialogue: parallel scientific advice with the European Medicines Agency. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.
* Horizon Scanning: topic identificatin, selection and Prioritisation for HTA cooperation

Visit website

Training on medicines’ research & development and patient engagement

Provided by European Patients' Academy (EUPATI) toolbox

EUPATI

EUPATI provides training for patients and patient representatives on the end to end process of medicines research and development. Trained patient experts are the core resource for patient involvement in medicines R&D, regulatory deliberations, and other patient engagement initiatives. EUPATI is committed to changing the face of patient engagement through patient education.

Visit website

Guide on patient partnerships in rare diseases research projects

Provided by European Joint Programme on Rare Diseases (EJP RD)

EJPRD

The EJP RD has developed a short guide on patient partnerships in rare diseases research projects. It aims to encourage fruitful, sustainable and enduring partnerships between scientists and patient organisations, co-leading the way for systematic patient-centered research.

Visit website

Training and capacity buildling of the rare disease research and care community

Provided by European Joint Programme on Rare Diseases (EJP RD)

EJPRD

The EJP RD Training and Empowerment program aims to develop knowledge and build capacity of the rare disease (RD) research and care community through the delivery of training programs on a wide range of relevant topics thereby providing opportunities to a large panel of stakeholders.

Visit website

Regulatory Service

Provided by EATRIS – EUROPEAN INFRASTRUCTURE FOR TRANSLATIONAL MEDICINE

EATRIS

Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product. Our range of services include:

– Expert opinion
– Orphan Drug Designation and Scientific Advice application at the EMA
– Pre-clinical and clinical plan development
– Informal scientific advice with selected national competent authorities, for highly complex projects
– Access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

Visit website