cr.appliance will be continuing its International Marbach Castle Workshop series on scientific and regulatory aspects of drug-drug interactions in 2013. The 4th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions (DDI) will take place in Marbach Castle Conference Centre, located at the Lake Constance, Germany.
The EUCARF Seminar "Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety" from 6th to 7th June 2013 in Freiburg provides the basis of the regulatory environment and processes that need to be followed related to pharmacovigilance. Furthermore the topics of pre- and post-approval obligations and the requirements and principles of pharmacovigilance of medicinal products and the method of pharmacoepidemiological studies are discussed.
The 8th BioValley Meet & Match Event with the topic "New cellular systems and their application in the human body" will take place on June 11, 2013 in Strasbourg. The event is organized by Alsace Biovalley and BIOPRO Baden-Württemberg. Companies and scientists from Alsace and Baden-Württemberg present their current state of research and ongoing projects in the field of novel cellular systems. The attendance is free of charge.
DAISY, the Symposium on Data Analysis in Life Science, commemorates the 10 year anniversary of the Nycomed Chair for Bioinformatics at the University of Konstanz. Renowned researchers from areas such as cheminformatics, machine learning, systems biology, image and data mining will present their vision of the challenges ahead: how to catch up with the enormous data variety that is hovering over us.
The EUCRAF coaching event "China strategy - The essentials to register and market pharmaceuticals in China" in Freiburg targets companies who seek orientation on the essentials to consider when bringing pharmaceuticals to China, either with or without a local partner company. The event provides an overview of the regulatory and legal framework to be considered in China and of the principles of a partnership with a local company.
The EUCARF Seminar "The roles of the supervising authorities and the essential characteristics of quality systems" from 17th to 19th July 2013 in Freiburg deals with the characteristics of a quality system and the particulars, the legislation and the guidelines of the Good Manufacturing/ Laboratory/Clinical Practice.
The EUCARF Seminar "Scientific advice, regulatory strategy and health technology assessment" from 4th to 6th September 2013 in Freiburg overviews the topics Regulatory strategy and global positioning of newly developed and existing products, Health Technology Assessment and how to lead and conduct appropriate scientific advice activities.
The EUCRAF Seminar "European pharmaceutical regulatory environment" in Freiburg provides the basis for all activities of a regulatory affairs professional since it imparts detailed knowledge on the pharmaceutical legislation, the regulatory institutions and stakeholders and their interaction. It furthermore deals with the particulars of small and medium size enterprises and all regulations related to biopharmaceuticals.