April 16th, 2018
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
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
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
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
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
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
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.
July 6th, 2017
A consensus paper just has been published! For early phase studies including first in human trials the unambiguous definition of healthy for enrollment of subjects has again and again been discussed controversially. To facilitate decision finding a consensus paper has just been published.
For detail see: https://link.springer.com/article/10.1007/s00228-016-2189-8.
February 1st, 2017
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 !
January 28th, 2017
The second part of the training course in early clinical development starts on February 1st, 2017. The training course offers the unique possibility to profit from the knowledge of highly experienced scientists. We are happy to host this course in our offices. So if you are interested, visit AGAH homepage for more details (www.agah.eu).
October 31st, 2016
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
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
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
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
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
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
July 31st, 2015
We just released the location plan of our clinical pharmacology unit in Erfurt where you can have a look into facilities and rooms. Please feel invited to have a look around!
You will get a first impression of our facilities – and in case of interest let us take you around, show you points of interest and inform you on all aspects of our clinical services.
May 30th, 2015
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…
May 16th, 2015
For the first time we will be present at a conference with an exhibition. Why? And why as a joint appearance together with 3 highly specialised CROs? More…
April 6th, 2015
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
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…
January 22nd, 2015
AGAH will realise a workshop on early clinical trials in oncology, held in Frankfurt on February 20th, 2015. More…