Publications
- 21-05-12 EBE Position Paper on Tendering of Biologicals, including Biosimilars
- The procurement practice is primarily used for medicines which are genuinely identical, bio-equivalent, multi-sourced and off-patent, i.e., small chemical molecules, so-called generics and their originators that have lost patent and exclusivity. However, the same criteria can not be applied when selecting and purchasing non-identical medicines, notably biologicals, including biosimilars.
- EBE Position Paper on Biologicals Tendering - final 03-05-2012.pdf
- (195.62kb) Download
- 01-07-11 Development Process of Orphan Medicines
- Development Process of Orphan Medicines
- (1534.345kb) Download
- 08-10-10 The EBE is developing a series of Concept Papers
The aim of the Concept Papers is twofold. First, to act as a practical implementation guide for manufacturers, bridging the gap between regulatory guidelines and manufacturing practice and, secondly, to facilitate dialogue and communication with the regulators.
Each Concept Paper will address a specific topic and the current publications include:
- Good Manufacturing Practice (GMP) for Advanced Therapies Medicinal Products (ATMP)
- (541.666kb) Download
- Multi-purpose Use of Plants
- (776.116kb) Download
- Multi-purpose Use of Plants (cover)
- (563.073kb) Download
- Comparability
- (986.171kb) Download
- Comparability (cover).
- (547.888kb) Download
- Critical Parameters and Continued Process Verification
- (3823.678kb) Download
- Critical Parameters and Continued Process Verification (cover)
- (534.677kb) Download
- 30-06-10 EBE Annual Highlights 2010
- EBE Annual Highlights 2010
- (1421.375kb) Download
- 29-06-10 EBE Brochure
- As the voice of biopharmaceuticals in Europe, EBE promotes a favourable scientific, business and regulatory environment.
more
- EBE Brochure 2010
- (645.259kb) Download
- 29-01-10 What is EBE & what's in it for my company?
- Flyer summarising the benefits of being a member of European Biopharmaceutical Enterprises trade association.
- EBE Triptych
- (609.484kb) Download
- 09-12-08 New EBE Publication on Benefit / Risk Balance: A Shared Responsibility
- The European Biopharmaceutical Enterprises association has initiated discussions on the benefit and risk balance of new therapies. EBE calls for a greater understanding of the roles played by the different stakeholders involved in the management of disease and the introduction of new medicines.
more
- Balancing Benefits and Risks
- (506.667kb) Download
- 10-04-07 Bio4EU study: "Consequnces, opportunities & challenges of biotech in Europe"
- Bio4EU study: "Consequnces, opportunities & challenges of biotech in Europe"
- (5988.637kb) Download
- 29-04-05 Fact Sheet on Biotech Solutions to Parkinson's Disease
- Researches are using biotechnology approaches to uncover new paths to treating patients. Biotechnology facilitating discovery & development of potential new treatments for Parkinson's disease.
- Parkinson Fact Sheet
- (163.094kb) Download
- 22-03-05 Orphan Medicinal Products White Paper
- The White Paper draft by EBE members highly experts in the field of Orphan Medicinal Products, is an analysis of the current situation in the field of OMPs and put forward 9 suggestions to optimise the framework around it.
- White Paper on OMPs
- (483.648kb) Download
- 01-11-04 Fact Sheet on Biotech Solutions on Alzheimer's Disease
Scientist working hard to develop new biotechnology treatments to help us have an healthy and happy older age. Altough many things about Alzheimer remain a mystery, research continues to bring us better understanding of the disease.
- Alzheimer's disease fact sheet
- (123.26kb) Download
- 31-08-04 Fact Sheet on Biotech Solutions to Osteoporosis
- New Biotechnology Treatments make aging less paintful. Thanks to biotechnology, the first true bone-forming agent is now available for treatment of Osteporosis.
- Osteoporosis Fact Sheet
- (177.501kb) Download
- 16-01-04 History of the Healthcare Biotech
- Milestone of discovery leading to concrete benefits to society.
- History of the Healthcare Biotech
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- 15-01-04 Fact Sheet on Biotech Solutions to Treat Haemophilia
- Concerns about product safety in development countries have been largely removed thanks to the development of biopharmaceuticals. Biotechnology offers a greater control over the manufacturing process, allowing significant reduction of risks of contamination through infectious pathogens. An example is blood products used to treat Haemophilia.
- Haemophilia Fact Sheet
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- 05-01-04 Fact Sheet on Biotech Solutions for Multiple Sclerosis
- Biotechnology allows for the development and products of new substances that were previously beyond the capacity of traditional technologies. This includes the design and production of new drugs with greater potency and specificity and, consequently, fewer side effects. One example of this is the treatment for Multiple Sclerosis.
- Multiple Sclerosis Fact Sheet
- (155.595kb) Download
- 01-12-03 Fact Sheet on Biotech Solutions to Cancer
- Major research efforts are underway to understand the mechanisms that allow cancer cells to grow. Biotechnology has given rise to better understanding and has already led to new treatments.
- Cancer Fact Sheet
- (222.538kb) Download
- 24-11-03 Fact Sheet on Biotech Solutions to Lysosomal Storage Disorders
- Biotechnology offers better product-targeting for specific diseases and patient groups, through the use of innovative technologies, in particular, genetics. An example include the treatments for Lysosomal Storage Disorders.
- Lysosomal Storage Disorders Fact Sheet
- (612.882kb) Download