Veranstaltungen

Practical GCP Compliance Auditing of Trials and Systems (Training Course)

Media-Partner

22.10.2014 - 24.10.2014

Practical GCP Compliance Auditing of Trials and Systems (Training Course)

London (UK)


This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as "advanced auditing", have become a basic task of many audit groups and are an essential element of inspections in Europe.
The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Biopharmaceuticals, Biosimilars and Advanced Therapies – Development and Regulatory Framework in Europe

Media-Partner

22.10.2014 - 24.10.2014

Biopharmaceuticals, Biosimilars and Advanced Therapies – Development and Regulatory Framework in Europe

London (UK)


This 3-day training course focuses on drug development of biopharmaceuticals which have become the focus of pharmaceutical innovation and currently represent 30 percent to 50 percent of newly authorised medicinal products. Participants will learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access. This covers the clinical trial stage, licensing and the life-cycle of these products. Specific development paths will be delineated, such as those for biosimilars and ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Clinical Statistics for Non-Statisticians (Training Course)

Media-Partner

23.10.2014 - 24.10.2014

Clinical Statistics for Non-Statisticians (Training Course)

London (UK)


This course answers common questions and addresses topics such as confidence intervals, hypothesis testing, trial designs, and methods for establishing non-inferiority.  This course will increase the level of statistical knowledge of nonstatisticians so that collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved. Course Level: Beginner

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

24.10.2014

Jülich Biotech Day 2014

Jülich

White biotechnology reduces our dependency on fossil fuels and offers large opportunities to synthesize platform chemicals, fine chemicals, pharmaceuticals and proteins using the biocatalytic power of microorganisms or isolated enzymes. At the Jülich Biotech Day, experts from academia and industry will present current highlights and trends in this exciting field of research and development.
Kontakt: Dr. Iris Eggeling, FZ Jülich GmbH
i.eggeling@fz-juelich.de

26.10.2014 - 29.10.2014

Getgeoweb – 2nd Transnational Workshop

Freiberg

The workshop deals with an important question: How to pursue from genomes to processes in the field of geo- and white biotechnology. Lectures will be about genome sequencing, genome mining, transcriptomic studies, gene identification, and the transfer into proteomics or even biocatalysis will be highlighted. An interesting mixture between methods and applications presented during the workshop as well as many posters will provide a wide view on the actual work of international leading groups in that fast evolving area of science.
Kontakt: TU Bergakademie Freiberg

28.10.2014

Von der Forschung zur Kommerzialisierung – Patente bei den Life Sciences?

Online

Ziel des kostenfreien Online-Seminars ist es, Existenzgründern, Businessplanwettbewerbs-Teilnehmern oder bereits erfahrenen Unternehmern Informationen zu Patenten und anderen gewerblichen Schutzrechten zu geben und etwaige Ängste vor der Materie zu nehmen. Es sollen insbesondere konkrete Fragen der Teilnehmer und mögliche IP-Strategien erörtert werden.
Kontakt: Science4Life e.V.
Tel.: +49-069-30 55 50 50, Fax: +49-069-30 52 70 21
info@science4life.de

28.10.2014 - 29.10.2014

HPLC-MS in der Spurenanalytik

Essen

Ein praxisnaher Überblick über Möglichkeiten der Strukturaufklärung, Quantifizierung sowie Störfaktoren. Der Kurs wendet sich an Laborleiter, wissenschaftliche Mitarbeiter und Laborpersonal, welche sich schon etwas mit HPLC-MS befasst haben oder planen, in dieses Gebiet einzusteigen. Es werden Kenntnisse der HPLC und der Grundlagen der organischen Analytik vorausgesetzt.
Kontakt: Haus der Technik Essen

29.10.2014 - 30.10.2014

Biodiversity and Food Security

Aix-en-Provence (F)

This international conference is the third in a series, organized by the French CNRS Institut Ecologie et Environnement (InEE) and the German Leibniz Association (WGL). hThe goal is to identify science-based solutions for global sustainability focusing on the issues of biodiversity and food security. Current ecological, economic and societal challenges for development require a holistic understanding of food security and environmental management: from this perspective, biodiversity can be seen as key to overcome trade-offs and to develop synergies between the food system and the conservation of landscapes, ecosystems, and species. The conference seeks to attract scientists from basic and applied research. It involves policy makers and other stakeholders concerned with biodiversity and food security themes who are interested in developing new solutions and strategies. It will connect researchers and stakeholders from natural sciences, social sciences, economics, humanities, technology and related fields.
Kontakt: Institut Ecologie et Environnement/Leibniz Association

29.10.2014 - 30.10.2014

1. Bioökonomie-Kongress Baden Württemberg

Stuttgart

Bioökonomie ist ein neues Modell für Industrie und Wirtschaft. Sie setzt auf nachwachsende Rohstoffe als Basis für Nahrungsmittel, Energie und Industrieprodukte. Und sie nutzt die Potentiale, die in Millionen Tonnen Bioabfällen und Reststoffen stecken. Mit diesem Modell soll langfristig die Abhängigkeit von fossilen Rohstoffen reduziert und mehr Nachhaltigkeit, Natur- und Klimaschutz erreicht werden. Das Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg hat 2013 ein Forschungsprogramm Bioökonomie ausgeschrieben, das der Vernetzung der im Themenfeld aktiven Standorte dienen und die interdisziplinären Zusammenarbeit fördern soll. Die im Rahmen des Programms geförderten Projekte werden im Sommer 2014 ihre Arbeit aufnehmen und sich auf dem Kongress präsentieren.
Kontakt: BioPro Baden-Württemberg GmbH

31.10.2014 - 01.11.2014

IMED 2014

Vienna (A)

The International Meeting on Emerging Diseases (IMED 2014) is organized by the International Society for Infectious Diseases (ISID) and its Program for Monitoring Emerging Diseases (ProMED-mail). Emerging infectious diseases are at the center of the world’s attention. The threats posed by pandemic influenza, bioterrorism and the realization that new infectious diseases may be recognized at any time, in any place, have dramatically raised our awareness and our need to understand emerging pathogens. What are the most important emerging disease threats? What biological, ecological, social and other factors lead to their emergence? How can we quickly detect their occurrences in order to respond in timely and appropriate ways? This meeting will fully embody the “one health” model of emerging diseases, recognizing the commonality of human and animal health.
Kontakt: Doris Steinbach, International Society for Infectious Diseases
Tel.: +43 1 481 19 48
doris.steinbach@isid.org

02.11.2014

China Forum 2014

Frankfurt am Main (GER)

A BIO-Europe pre-conference: What does it take to succeed in the 2nd largest healthcare market? The event brings together China-based life science executives with ther counterparts from Europe and across the globe.
Kontakt: Thomas Voigt, EBD Group
Tel.: +1-760-930-0500
tvoigt@ebdgroup.com

Signal Management in Pharmacovigilance (Training Course)

Media-Partner

03.11.2014 - 04.11.2014

Signal Management in Pharmacovigilance (Training Course)

Paris (F)


Signal Management is a critical process of Pharmacovigilance required by EU Good Pharmacovigilance Practice. It is the scientific component that underpins Pharmacovigilance, and the very reason why Pharmacovigilance was created in the first place. The entire course has been updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX - Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII. Time has been set aside for exercises, questions and discussions. The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions. Data mining techniques for large volume ADR data analysis and relevant EMA guidelines will also be a discussed, as well as a future outlook.

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Essentials of European Regulatory Affairs (Training Course)

Media-Partner

03.11.2014 - 04.11.2014

Essentials of European Regulatory Affairs (Training Course)

Paris (F)


This is the must-attend training course for anyone needing to learn the essentials of European Regulatory Affairs - it has been extended to two days to include more topics, and it is kept up to date in minute detail by the experienced faculty.
The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European Networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. In addition the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed. This will cover the different steps and timelines in the different procedures, the clock-stops, the compiling of questions etc. An introduction regarding the lifecycle will be given by information in respect to pharmacovigilance, variations and renewals.

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

How to Prepare for Pharmacovigilance Audits and Inspections (Training Course)

Media-Partner

03.11.2014 - 04.11.2014

How to Prepare for Pharmacovigilance Audits and Inspections (Training Course)

Paris (F)


Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach how to prepare for an audit / inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

BIO-Europe 2014

Media-Partner

03.11.2014 - 05.11.2014

BIO-Europe 2014

Frankfurt am Main (GER)


Biotechnology partnering conference. BIO-Europe features the industry’s most advanced Web-based partnering system, enabling delegates from all parts of the biotechnology value-chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward.

Kontakt: Thomas Voigt, EBD Group
Tel.: +1-760-930-0500
tvoigt@ebdgroup.com

03.11.2014 - 05.11.2014

2nd Annual Conference of the German Stem Cell Network

Heidelberg (GER)

The Conference will cover the latest topics in basic and applied stem cell research. Beside selected international keynote lectures many scientists will get the chance to present their work to a wide forum. Contributions on clinical applications in regenerative medicine, industry presentations and an indutry exhibition will reflect the strong translational impact of the stem cell research.
Kontakt: German Stem Cell Network (GSCN)
gscn.office@mdc-berlin.de

05.11.2014

Mythos Orphanisierung?!

Berlin

Die so genannten Orphan Drugs, Medikamente im Bereich der "Seltenen Erkrankungen" unterliegen besonderen Zulassungsregularien, um ihre Entwicklung zu fördern. Daraus entsteht vielfach der Verdacht, dass die Industrie aus häufigen Erkrankungen „Seltene“ mache, indem sie mehr oder weniger willkürliche Indikationsuntergruppen bildet. Dadurch wird die Zulassung und Markteinführung ihrer "Orphan Drugs" vereinfacht - es entsteht der "Mythos der Orphanisierung". Um diesem Mythos auf den Grund zu gehen, lädt die ACHSE gemeinsam mit der vfa bio zu der Veranstaltung in der Kalkscheune in Berlin ein.
Kontakt: ACHSE e.V./vfa bio

Essentials of Clinical Study Management (Training Course)

Media-Partner

05.11.2014 - 07.11.2014

Essentials of Clinical Study Management (Training Course)

London (UK)


The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members, and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems, offer creative solutions and develop strategies to mitigate risk. This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study from protocol to final report.

Kontakt: DIA Europe
Tel.: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

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