October 11th, 2017

1st GBHI-Conference – Conference Report now available

A summary report just has been published in the European Journal of Pharmaceutical Sciences with contribution of authors from European authorities, US-FDA, industry, CRO and universities. The paper presents the outcome of the conference held in spring 2015 in Amsterdam. As stated by the authors the summary of the 2nd GBHI conference (autumn 2016 in Washington) will follow soon.

For detail see: https://www.ncbi.nlm.nih.gov/pubmed/28964950

September 21st, 2017

3rd GBHI conference – program is online

Do not miss this conference in Amsterdam 2018: http://eufeps.org/conferences/3rd_GBHI!

Topics are: summary of 2nd GBHI conference in Washington 2016, necessity of multiple dose studies in BE testing, BE assessment of transdermal patches (including adhesion and skin sensitization / irritation studies) and BE of liposomal parenteral preparations.

We look forward to meeting you in Amsterdam next year.

February 1st, 2017

German Pharm-Tox Summit 2017 in Heidelberg

This joint conference of all relevant pharmacological societies in Germany will be held by DGPT together with VKliPha and AGAH from 6–9 March 2017. SocraTec R&D sponsors the activities by overtaking travel costs from overseas speaker to allow for high-level sessions under the responsibility of VKliPha.

About 900 participants enjoy the exciting and versatile program. SocraTec R&D is present in a workshop about  early clinical trials in special populations with a presentation about DDI and BE studies in oncology initiated by AGAH. Furthermore, we contribute to a session about individually tailored pharmacotherapy and to a session upon new developments in PKPD modeling, both initiated under the responsibility of VKliPha.

Don’t miss it !

October 31st, 2016

Introductory Course in Exploratory Medicines Development – taking place in our offices in Oberursel!

A condensed and intensive training course in early clinical development – given by highly experienced scientists in small groups: AGAH has developed such a 6 days course – split into two parts of 3 days – which helps you to get a comprehensive insight into methods, scientific background and regulatory context. Due to AGAH being a Non-profit organisation the price is really affordable. We are happy to host this course in our offices. So if you are interested, visit AGAH homepage for more details (www.agah.eu).

September 20th, 2016

2nd Global Bioequivalence Harmonisation Initiative – a great success

The 2nd GBHI conference in Washington from September 15th – 16th, 2016, was a great success. Intensive discussions from competent and experienced participants and representatives from agencies worldwide striving for compromises featured the meeting ending with the conclusion of all participants that a continuation of the harmonization process is highly appreciated. A follow-up conference is planned to be realised in Amsterdam, presumably in spring 2018.

We at SocraTec R&D were happy to contribute – and we look forward to the next conference.

September 6th, 2016

Quality Management Systems in Early Phase Trials

Join us at the AGAH Meeting in Bonn (www.agah.eu). The 2-days workshop gives an excellent insight into quality management systems in early clinical trials from the perspective of CROs, sponsors and authorities. The first day focuses on the systems themselves whereas the second day is dedicated to the inspector’s perspective. Intense discussions and insider knowhow – an exciting mixture!

August 16th, 2016

Trial in drug-induced xerostomia published

Together with Institut Recherche Pierre Fabre and Pierre Fabre Medical Devices SocraTec R&D successfully performed a clinical trial to evaluate the efficacy, safety, and tolerability of three different saliva substitutes in adult subjects with drug-induced xerostomia and documented hyposalivation.

Recruitment and clinical performance was realised by our clinical team in Erfurt supported by the dental expertise of Dr. Frank Donath.

The study was just published http://onlinelibrary.wiley.com/doi/10.1002/cre2.29/pdf.

July 25th, 2016

2nd Global Bioequivalence Harmonisation Initiative in Washington

We would very much appreciate meeting you in Washington at the second conference of EUFEPS together with AAPS (September 15th and 16th, 2016). This Conference is planned as platform for scientists from the pharmaceutical industry and academia to exchange their experience and views with the regulators and engage in active regulatory discussions. The focus is set on Prodrugs and Compounds woth pre-systemic extraction, highly variable drugs and on exclusion of PK data in BE assessments.

Contribute to a highly interesting scientific and regulatory exchange and get an idea about differences and similarities in regulatory’s thinking.

March 29th, 2016

Routine GCP inspection successfully passed

The 3-day routine GCP inspection of local authorities was again successfully passed and included also our clean room for reconstitution of cytostatic drugs. The clean room and its maintenance and hygiene concept were fully accepted.

December 17th, 2015


Santa Claus is participating in a clinical study at SocraTec this year !

Image sources: SocraTec R&D / © Milles Studio – Fotolia.com / baehring.net


May 30th, 2015

Workshop: New Guideline on Modified Release Products

The new European guideline defining the requirements on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)  comes into effect on June 1st, 2015. We would like to draw your attention to a workshop planned and realized by AGAH together with the EUFEPS Network on Bioavailability and Biopharmaceutics More…

April 6th, 2015

Basic Course on Human Pharmacology

AGAH has initiated a course schedule for basic human pharmacology education. The course is split into 2 parts, together giving insight into all relevant aspects of human pharmacology. More…

April 6th, 2015

Global Bioequivalence Harmonisation Initiative (GBHI)

Since decades, bioequivalence is considered one of the key questions in new and generic drug product development and registration worldwide. At the same time, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country and continent to continent, although the scientific basis for it is globally the same. This aspect, and the on-going discussion on the suitability of reference products purchased from a specific country and their applicability for submissions in other countries or regions, create the necessity to conduct several only slightly different bioequivalence studies to get the same product authorised in various markets. More…


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