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Online workshop “Environmental risk assessment of medicinal products for human use”

13.4.2021  9:00 – 12:00 (MESZ)

In 2006 the requirement for a preparation of environmental risk assessment of active pharmaceuticals ingredients of medicinal products was introduced. Also affected by the REACH regulation (EC no 1907/2006) evaluating the environmental behaviour of chemicals in detail, the environmental impact of medicinal products has become increasingly important.
Hence, the authorities are more and more demanding the fulfilment of the requirements of the ERA Guideline that has been supplemented by various Q&A documents aimed at providing clarification and to harmonise the use of the still valid guideline from 2006.
The need of revision of the guideline has become evident but still there is currently only a draft version available. The impact of the changes of the guideline on ERA will be discussed in the seminar.
Significantly improved analytics make it possible to detect active pharmaceutical ingredients in the lowest concentrations in environmental compartments. The behaviour and effects of medicinal products are becoming the focus of public attention. In particular the discussion of endocrine descriptors is becoming increasingly important.
The online seminar is structured as a basic course for the preparation of ERAs for active pharmaceuticals ingredients of medicinal products for human use (non-GMOs) based on the regulatory requirements outlined in the guidance on the environmental risk assessment published by the European Medicines Agency (EMA).

This online workshop is structured as a basic course for the preparation of ERAs for medicinal products for human use (non-GMO) based on the regulatory requirements outlined in the Guidance on the Environmental Risk Assessment of Medicinal Products for Human Use of the European Medicines Agency (EMA).

Structure of the online workshop

08:45 Opening of the waiting room
09:00 I.  Introduction and Phase I assessment
– Regulatory requirements
– Exceptions from an ERA
– Impact of the new draft guideline
– General overview of ERA process
– Phase I assessment
Prof. Dr. C. Allgaier
09:45 II. PBT assessment
– Embedding in the ERA process
– Screening steps
– Definite assessment for P, B, and T
Dr. S. Franz
10:15 Discussion Prof. Dr. C. Allgaier/Dr. S. Franz
10:30 Break
10:45 Phase II assessment
General overview of Phase II
– Phase II, Tier A (physico-chemical properties, aquatic compartment, microorganisms, bioconcentration, sediment and terrestrial compartment; risk assessment)
– Phase II, Tier B (compartment specific refinement)
Dr. S. Franz
11:45 Discussion Prof. Dr. C. Allgaier/Dr. S. Franz
12:00 End of workshop

The presentations are held in English. There will be time to answer your questions.

The seminar will be addressed to staff of regulatory and medical affairs, R&D manager, employees of testing facilities and consultants.

Organizer

ACA-pharma concept GmbH
BioCity Leipzig
Deutscher Platz 5, Leipzig


Speaker

Clemens Allgaier PhD, Professor of Pharmacology and Toxicology, Graduate (Bio-)chemist

Stephanie Franz PhD, Geoecologist

Registration fee

Registration fee

345,- €* (plus VAT) for the participation of the online workshop. Payment upon receipt of invoice; participation in the workshop requires payment. The access code will be sent 1 day before the online workshop. Registration deadline is 09.04.2021.

*Cancellation conditions: Please understand that we have to charge a processing fee of 50,- € for cancellations up to 2 weeks before the event. In case of cancellation up to 1 week before the start of the event, 50% of the participation fee will be charged. After that, the full participation fee will be charged. However, you could also name a substitute participant from the same registering company. In case of cancellation by the organizer, you will receive a full refund of fees already paid.

Technical notes

Technical  notes

To participate in an online workshop, you need a PC/laptop or tablet with internet connection and sound card, as well as the latest version of an internet browser. The use of the zoom app is recommended.

We will open the waitin room 15 minutes before the start of the presentations to clarify possible technical questions. You are welcome to use the chat to send us your questions and comments.

Contact
ACA-pharma concept GmbH
Telefon: +49 (0) 3 41 33 73 33 63
Fax: +49 (0) 3 41 33 73 33 67
E-Mail: aca_campus@aca-pharma.eu

Online registration

registration deadline 09.04.2021

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