Click here for the online version of the Newsletter.


[Dear Sir or Madam,

With this newsletter we would like to inform you about the following current trends in the area Blood and Biologics.

Your
ECA Team


1. FDA Guidance on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components

In addition to the existing guidance on donor eligibility, the FDA published a new guidance document on " Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use"

↑ top

2. Pharmaceutical Biotechnology for Non-Biotechnologists
 

In this course from 5-6 October 2016 you will get an overview of as well as an insight into pharmaceutical biotechnology. It will also present the opportunities of biotechnology in GMP manufacturing. Please see the programme for further information.

↑ top

3. Revised Recommendation related to Transmission of Zika Virus

Relating to the fast developments in Zika Virus transmisions, the FDA now published a guidance for Industry with Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.

↑ top

4. A practical View on the Development and Manufacture of Biosimilars

Especially the proof of their biological similarity with the originals poses a tremendous challenge in the development and manufacture of biological generics. Therefore, take advantage of Biosimilars - Case Studies and practical Advice as part this year's PharmaLab on 8/9 November to learn from the experience of professionals from industry and authorities.

↑ top

5. Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

The US Foood & Drug Administration (FDA) published an Draft Guideline on the Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products.

↑ top

6. GMP Challenges for Vaccine Manufacturing
 

This ECA course on 6/7 December 2016  will give you the possibility to get familiar with the theoretical background as well as with the practical implementation of GMP requirements in the vaccine production. A combination of theoretical background lectures and practical case studies will show you how to do it in real life. Please see the programme for further information.

↑ top

7. In case you missed the previous Blood & Biologics Newsletter, here are the news from the last Blood & Biologics Newsletter:

For further recent news please go here.

↑ top

8. Forthcoming GMP/FDA Events

Here you will find an updated overview of forthcoming education courses and conferences.

↑ top


Yours sincerely,

The European Compliance Academy


We have entrusted the following service provider to send this message to you:
Concept Heidelberg GmbH, Rischerstraße 8, 69123 Heidelberg, Germany
Managing Director: Oliver Schmidt - Registration: HRB Mannheim No. 705125
The information contained in this e-mail is the copyright of Concept Heidelberg GmbH. The content (or parts of it) may only be used with the express permission of Concept Heidelberg GmbH.
The contents of the GMP Newsletter have been compiled with great care. However, we cannot guarantee the completeness, accuracy and topicality of the contents.

↑ top