Events

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

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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.

Contact: DIA Europe
Phone: +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

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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.

Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Clinical Statistics for Non-Statisticians (Training Course)

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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
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

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.
Contact: Institut Ecologie et Environnement/Leibniz Association

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.
Contact: Doris Steinbach, International Society for Infectious Diseases
Phone: +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.
Contact: Thomas Voigt, EBD Group
Phone: +1-760-930-0500
tvoigt@ebdgroup.com

Signal Management in Pharmacovigilance (Training Course)

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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.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Essentials of European Regulatory Affairs (Training Course)

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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.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

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

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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.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

BIO-Europe 2014

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

Essentials of Clinical Study Management (Training Course)

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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.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

06.11.2014

EVCA Venture Capital Forum 2014

Berlin

Cross-sector venture capital event. As participants are expected early stage to late stage/growth capital VC firms investing across all industries to join to debate the unique challenges and opportunities of investing and operating in Europe.  
Contact: European Private Equity and Venture Capital Association
events@evca.eu

ISPE/DIA Workshop on Computer Systems Compliance – Maintain Data Integrity to Reduce Risk for the Patient

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06.11.2014 - 07.11.2014

ISPE/DIA Workshop on Computer Systems Compliance – Maintain Data Integrity to Reduce Risk for the Patient

Basel (CH)

This 2-day conference will provide a forum for information, discussion on conceptual and practical questions and experience exchange through lectures, panel discussions, and interactive workshop sessions. It will focus on the work being conducted by two leading organisations within the life sciences sector who approach the subject from differing directions but with the same clear objective of ensuring data integrity to reduce the risk to the patient. It will focus on the well-established approaches used, identifying the similarities of key principles and practice, and the challenges facing the industry with the availability of new technologies such as cloud computing.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Benefit/Risk Management Training Course

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10.11.2014 - 11.11.2014

Benefit/Risk Management Training Course

Barcelona (ES)

The balance of benefits and risks of a product is the basis for all key decisions in the pharma industry. Thus the balance must not be left to chance – it can be and should be effectively managed. This intensive course explores current opportunities made possible by the new legislation, advances in information technology and a new scientific methodology to enhance and modernise the approaches in the product lifecycle management.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

Clinical Project Management - Part II

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10.11.2014 - 12.11.2014

Clinical Project Management - Part II

Barcelona (ES)

As clinical trials become more complex and there is increasing demand for efficiency and cost effectiveness, the knowledge and skills required to manage all aspects of a clinical project are critical. This course provides a comprehensive foundation in clinical project management. Using the Project Management Body of Knowledge (PMBOK®) as a guide, participants will be taught how to apply project management strategies, tools and techniques to their clinical trial projects.
In two independent modules of three days each, the following topics will be covered:
- Project Definition and Organisational Context
- Project Management Tools and Techniques
- Scope Management, Resource Estimating and Budget Management of a Clinical Trial
- Project Quality Management
- Project Risk Management
- Communication and Stakeholder Management
- Procurement Management
- Team Management and Leadership Skills
This training course is geared toward professionals who desire a comprehensive foundation in clinical project management. Participants should have at least two years of clinical trial experience, or have completed the DIA training course “Essentials of Clinical Study Management.”
This "Clinical Project Management" training course is targeted at an intermediate/advanced level.
Contact: DIA Europe
Phone: +41 61 225 51 51, Fax: +41 61 225 51 52
diaeurope@diaeurope.org

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No liability assumed, Date: 22.10.2014


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