Die zweitägige Fachveranstaltung bietet Experten und Interessierten aus dem Bereich der Produktion von Medizintechnischen Geräten und Instrumenten eine Plattform für den Informationsaustausch und für individuelle Gespräche. more

Upon completion of this course, attendees will gain a clear understanding of the batch record review expectations of regulatory agencies and discover the elements of an effective batch record reviewer training program. more

Upon completion of this course you will have a clear understanding of international regulatory authority regulations and expectations and will have gained the background knowledge necessary to effectively plan and execute QC test method validation programs. more

Insights and practical suggestions on how to develop and manage a clinical phase-dependent CMC regulatory compliance strategy for biopharmaceuticals and biologics are offered in this course. more

This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. more

Course notes and interactive exercises address how to write effective correspondence and reports in support of the company’s activities. You will learn how to organize and deliver information for the intended audience. more

Free admission, no registration.

This year’s event is devoted to polymers. Modern polymer chemistry encompasses many innovative fields of research such as high tech materials, medicines and nanotechnology. New products are created by chemists, physicists, biologists, engineers and doctors working in close collaboration. more

This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. more

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This course presents a comprehensive overview of process writing that the binding regulations require. more

Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug. more

Upon completion of this course, attendees will have an understanding of the framework for Design V&V, Risk Analysis and recommendations to effectively meet the regulatory requirements relating to these. more

This course addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant. more

Programm
11:00-12:00 Lab Tour (separate Anmeldung folgt)
12:15-13:00 Mittagessen für Lab Tour Teilnehmer
13:00-13:30 Empfang mit Kaffee und Kuchen
13:30-16:35 Vorträge; inkl. 30 min Networking Break
16:40-17:30 Workshop
17:30-19:30 Apéro Riche: (Köstlichkeiten aus der Römerzeit) more

This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. more

The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in the EU and individual European countries. more

Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices in the European Union. more

Stem cell research and therapy continues to make significant advancements in medical treatments. The aim of the conference is to showcase these developments with focus on regenerative medicine. Conclusions to 2009 presentations and debates put adult stem cells firmly on the map of advanced and promising clinical applications. This conference investigate new areas of research from the laboratory to current clinic uses. more

Business trip to Washington DC

• Become more familiar with the US medtech market and explore its opportunities and challenges
• Visit the AdvaMed 2010 in Washington D.C., the leading medtech conference in the United States
• Meet successful Swiss entrepreneurs in the US for an open exchange of experiences
• Discuss with local industry stakeholders and agency experts and get first hand information on changes in health care policy and in the regulatory environment
• Meet with executives of US companies and build your business relation

Discount for Swiss companies.

AdvaMed2010 is the premier MedTech Conference for CEOs, business executives, policy-makers, financiers, media, and industry stakeholders from around the world. more

The course will discuss the regulatory expectations and other industrial references/standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services. more

This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. more

This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions. more

This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs that are completed on time, within budget, and most importantly completed with a high level of quality and performance. more

This course will give participants the background and history of the US Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. more

Providing a step-by-step foundation for determining product shelf life through stability testing, this comprehensive training course outlines the issues and guidelines surrounding FDA and ICH regulatory requirements. more

Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. more

The topic is of interest to all those who work on innovative projects, especially those involved in research at universities, who are about to start their own company, or who are interested in the significance of Switzerland's asset as knowledge and science site.

The conference language is German exclusively more

Join the Swiss Pavliion!

Medica is considered to be the most important world exhibition of medical technology. MEDICA presents a remarkable portfolio of products, topics and companies, from innovative small businesses to  medium-sized companies and even global players. Numerous countries regularly exhibit the products of their enterprises on their respective national pavilions. In 2009, the most recent developments and materials of more than 4’300 exhibitors from more than 60 countries have taken up a surface on 20 halls. The number of visitors coming from 100 countries totalled 137’000. more

ISMICT 2011 will continue and extend the tradition established in Japan, Finland, Canada and Taiwan. The focus this year will be on Medical Body Area Networks, Technology and Services for Personalized Medicine. more