European Conference on APIs

Europe's leading event on active pharmaceutical ingredients takes place on 24-26 October, 2018 in Budapest, Hungary.

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Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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ECA WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

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Latest GMP News

Oct 18

Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place ...

You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.

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Oct 18

EU guidance for new Medical Device Regulation (MDR) ...

With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.

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Oct 18

Borderline questions on medical devices ...

At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.

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Oct 18

Sponsor Oversight - Metrics & Case Studies ...

The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.

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Oct 18

What is required for electronic informed consent (eConsent)? ...

The MHRA released a joint statement setting out the legal and ethical requirements for documenting consent using electronic methods. Read more about the MHRA´s view of seeking consent electronically (eConsent).

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Oct 17

New defect Evaluation List for Moulded Glass out now ...

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Moulded Glass which includes an appendix with example pictures of specific defect characteristics is out now.

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