In the following, we would like to update you on current changes in the regulatory framework (OECD, ICH and others), inform you on upcoming congresses (including where you can meet us in person) and add information on the company and recent novelties.

Dates / Congresses

Joint ETS/ESTP Annual Meeting 2019

We are proud to announce that ETS (European Teratology Society) and ESTP (European Society of Toxicologic Pathology) will join their annual meetings in 2019 and welcome you September 17 – 20, 2019 in Cologne. You can meet us there!  
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Legislative change

New EMA Draft Guideline for Environmental Risk Assessment of Medicinal Products

At the end of 2018, the European Medicines Agency published the new draft Guideline on the environmental risk assessment of medicinal products for human use  for public consultation. Deadline for comments will be 30 June 2019.
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Nonclinical Safety Testing Guideline S11

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) issued the first draft of guideline S11 on Nonclinical Safety Testing in Support of Development of Pediatric Medicines in September 2018.
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OECD Guideline 414 Update

OECD Guideline 414 (Prenatal developmental toxicity study) was recently (25 Jun 2018) updated and now includes additional endpoints to increase the possibility of detecting endocrine disrupting chemicals.  
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Worth knowing from the authorities

EFSA Dietary Reference Values

The European Food Safety Authority published their “Dietary Reference Values for Nutrients” in a Summary Report. Dietary reference values (DRVs) is an umbrella term for the complete set of nutrient reference values which include population reference intakes (PRIs), the average requirements (ARs), adequate intakes (AIs) and reference intake (RIs) ranges for macronutrients. In 2005, the European
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BfS Annual Report 2017/18 published

The Federal Office for Radiation Protection (BfS) issued its Annual Report 2017/2018, including updates on prevention of UV-associated diseases, on the situation of radiation protection for patients in medicine and on occupational radiation protection.     
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Drug Safety Mail 2018-66

On 11 Nov 2018, the Arzneimittelkommission der deutschen Ärzteschaft (AKdÄ) issued a Drug Safety Mail on severe and long-lasting side effects of fluorochinolone antibiotics on muscles, joints and nervous system based on information from the German BfArM.  
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“In your own case”

Changes in Company Management

Lars Mecklenburg,  co-founder of PRECLINICAL SCIENCE, has decided to discontinue consulting. Lars will no longer accept new clients but will be available for existing clients regarding previous projects. His reponsibilities around pathology have been transferred to Robert Klopfleisch and his duties around preclinical drug development projects have been taken over by Roman Föll and Geertje
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Alternative Advances in Zoological and Medical Terminology

The discovery and detailed scientific description of new zoological and medical entities is a slow and work intensive process. After the scientific description of the genus Rhinogradientia (by Gerolf Steiner, 1961) and the species Steinlaus (Petrophaga lorioti, 1976), finally the medical world now faces the first detailed work on etiology, epidemiology, clinical symptoms and treatment
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Shift to new research strategies in preclinical drug development

Over the last decade, a shift in paradigms was initiated, focussing on the development, validation and regulatory acceptance of non-animal testing strategies in toxicology. The Netherlands National Committee for the protection of animals used for scientific purposes (NCad) issued an opinion paper on objectives and transition strategies. The complete dossier can be assessed here:   ncad-opinion-transition-to-non-animal-research
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