May 16th, 2018

22nd PKPD Expertentreffen in the heart of the Black Forest

As always, the meeting was completely booked out! The participants enjoyed exciting insights into PKPD aspects of biologics. The plenary lecture of Tine Karlson (Norway) about the relevance of the lymphatic system was a real highlight. The sessions “Kidney reloaded” and “Cancer Immunotherapy” were perceived as very good and informative. Antje Walz from Roche was a great host! And finally the “Hans Günter Schäfer Award” went to Miro Eigenmann for a project from the University of Bergen together with the Roche Innovation Centre about PK modelling of interstitial antibodies.

April 16th, 2018

3rd GBHI in Amsterdam: lively discussions and intensive exchange with authorities

The conference demonstrated that consensus is difficult to achieve and only small steps are possible wherever diverging standards have been defined long ago. Yet, when authorities are still struggling for the best solution, early contribution of experts from industry, CROs and academia is extremely fruitful. This became evident for irritation and sensitisation studies with patches as well as for studies with liposomal formulations.

As new and innovative feature, a monkey survey was introduced allowing the participants to vote for solutions.

April 11th, 2018

Meet us in Amsterdam: 3rd GBHI Conference starts soon (12 – 13 April 2018)

The GBHI conference starts with a summary of the preceding conference in 2016 in Washington, followed by the topics “Necessity of multiple dose studies”, “Transdermal Therapeutic Systems” and “Liposomal parenteral formulations”.  Vivid discussions between authorities, industry and university are expected.

This meeting is a must-attend for everyone involved in planning and realisation of bioequivalence trials. For more information, please visit the official website.

March 21st, 2018

Meet us in Munich: AGAH Annual Meeting 26 – 27 April 2018

The annual meeting this year focuses on predictability and prediction of Adverse Reactions related to target organs in early drug development, starting with an exciting plenary lecture of Sir Munir Pirmohamed about hypersensitivity and adverse drug reactions. Hot topics are prediction of ADRs in kidney, liver, CNS and the heart followed by local ADRs and immune system.

This meeting is a must-attend event for everyone involved in planning and realisation of early phase trials.

March 15th, 2018

Regorafenib: first in human as eye drops

We tested regorafenib eye drops in healthy subjects to assess ophthalmic tolerability, safety and systemic exposure. This is the first time regorafenib was administered to the eye. For details see the recently published paper in the British Journal of Clinical Pharmacology.

March 9th, 2018

3rd GBHI conference – all speakers confirmed

All speakers for the 3rd GBHI conference have been confirmed!

The main topics selected for this year’s conference are: Necessity of multiple dose studies in BE testing, BE of Transdermal Delivery Systems, and BE of liposomal parenteral preparations. In addition, unresolved thematic aspects from the previous conference will be taken up again with the intention to achieve further consensus.

The conference takes place in Amsterdam from April 12-13, 2018. For more information, please visit the official website.

We look forward to meeting you in April!

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

IMPORTANT NOTICE: CHRISTMAS CANCELLED!

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

strud_santa_4_wordpress
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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