Advanced Therapies Partners

http://www.at-partners.eu

Advanced Therapies Partners (ATP) is a specialized counselling company for the development and introduction to the markets of products and treatments from the field of ‘Novel Therapies’ (Advanced Therapy Medicinal Products, ATMP). We are specialized in somatic cell therapy and tissue therapy, especially in stem cells applications and human tissue engineering.

ATP will accompany you in your innovative journey beginning from the pre-clinical studies until the marketing approval, offering guidance and counseling regarding the legal regulations and taking part in the strategic und operative planning for the pre-clinical studies, clinical trials and the request for authorization. Our ATP team offers you a long-term experience in development and translation of advanced therapies and a large network of specialists.

What ATP offers, is targeted at scientific, big as well as small companies, investors, institutes, public organizations, and international companies which aim to develop and market ATMP in Germany and Europe. 

 

 

 

BioTOP Berlin-Brandenburg
http://www.biotop.de

The aim of BioTOP is to initiate and align biotechnological projects by interlinking all relevant players in order to establish Berlin-Brandenburg as a globally leading location for competence in biotechnology.

 

Bundesinstitut für Arzneimittel und Medizinprodukte
http://www.bfarm.de/http://www.bfarm.de

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health. The authority's seat was transferred to Bonn in the course of the Government's move to the capital. The BfArM is the successor to the Institute for Drugs (Institut für Arzneimittel) founded on 1 July 1975 as part of the now dissolved Federal Health Office (Bundesgesundheitsamt, BGA).

 

CDISC, Clinical Data Interchange Standards Consortium
Internationale Seite: http://www.cdisc.org/
Deutsche Seite: http://www.ecdisc.org/

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.

 

CIPS, Collegium Internationale Psychiatriea Scalarum
http://212.114.150.241/main.php

CIPS is a scientific association whose aim is to develop scientific methods for quantification of psychopathological findings as well as mental state features and capability characteristics in clinical trials and for evaluation of therapeutic procedures in pharmacopsychiatry and -psychology and their related fields or for evaluation of psychometric procedures, especially in their application in clinical trials.

 

EMA – European Medicines Agency
http://www.emea.europa.eu/http://www.emea.europa.eu

The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

 

EMWA, European Medical Writers Association
http://www.emwa.org/

EMWA is the European Medical Writers Association. It supports medical writers and medical editors through training and networking opportunities. EMWA is a great place to pick up the skills needed to broaden your horizons as a medical writer. EMWA's aim is to provide educational and social networking opportunities for its members.

 

European Commission – Pharmacovigilance Guideline - Volume 9A
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol9_en.htm

Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use. For medicinal products for human use, such guidelines are drawn up by the European Commission in consultation with the EMEA, Member States and interested parties in accordance with Article 106 of Directive 2001/83/EC as amended and Article 24 of Council Regulation (EEC) No 2309/93. For medicinal products for veterinary use the relevant articles are Article 77 of Directive 2001/82/EC as amended and Article 46 of Council Regulation (EEC) No 2309/93.

 

GMDS, Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V.
http://www.gmds.de/

 

IBS, International Biometric Society
Internationale Seite: http://www.tibs.org/Interior.aspx
Deutsche Seite:  http://www.biometrische-gesellschaft.de/

The International Biometric Society is an international society promoting the development and application of statistical and mathematical theory and methods in the biosciences, including agriculture, biomedical science and public health, ecology, environmental sciences, forestry, and allied disciplines. The Society welcomes as members statisticians, mathematicians, biological scientists, and others devoted to interdisciplinary efforts in advancing the collection and interpretation of information in the biosciences. The Society publishes two journals, Biometrics, reporting communications consistent with the Society's mission, and, jointly with the American Statistical Association, the Journal ofAgricultural, Biological, and Environmental Statistics.

 

ICH, International Conference on Harmonization
http://www.ich.org/cache/compo/276-254-1.html

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.

 

Paul-Ehrlich-Institut
http://www.pei.de/http://www.pei.de

The Paul-Ehrlich-Institut is an institution of the Federal Republic of Germany. It reports to the Bundesministerium für Gesundheit (Federal Ministry of Health).

 

Reference- and Translation Center for Cardiac Stem Cell Therapy (RTC) at Rostock University
http://www.cardiac-stemcell-therapy.com/index.phphttp://www.cardiac-stemcell-therapy.com/index.php

At the Reference- and Translation Center for Cardiac Stem Cell Therapy (RTC) at Rostock University novel examination methods with stem cells for heart diseases are being investigated and applied. The aim is to enable the long-term healing of the damaged heart on the basis of regenerative medicine.

 

University of Applied Sciences Berlin (Beuth Hochschule für Technik Berlin) – Master’s program “Clinical Trial Management”
http://www.beuth-hochschule.de/ctm