• gmp-verlag.de
  • GMP Compliance Adviser Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

Award for the
GMP Compliance Adviser

GMP knowledge that convinces.

Image

On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".


TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.


2. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.


3. GDP Audit Questionnaire
More than 700 questions with reference to regulations.


4. A Pharma Guide to Cleaning Validation
How to meet Agency Expectations and Establish Accepted Limits.


5. Data Integrity in the EU
Requirements for Quality Management Systems.


>>> More Downloads

News about GMP/cGMP

2017-08-22

Applications to host EMA Headquarters

The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The agency will need to be relocated in the context of the UK's withdrawal from the EU. There have been 19 offers to host the European Medicines Agency (EMA).

 

The cities that have applied to host the EMA as of 1 August 2017 are:

  • Amsterdam, The Netherlands
  • Athens, Greece
  • Barcelona, Spain
  • Bonn, Germany
  • Bratislava, Slovakia
  • Brussels, Belgium
  • Bucharest, Romania
  • Copenhagen, Denmark
  • Dublin, Ireland
  • Helsinki, Finland
  • Lille, France
  • Malta
  • Milan, Italy
  • Porto, Portugal
  • Sofia, Bulgaria
  • Stockholm, Sweden
  • Vienna, Austria
  • Warsaw, Poland
  • Zagreb, Croatia

The Commission's assessment will be published online 30 September 2017, then the European Council will have a political discussion based on the assessment at the General Affairs Council (Article 50 format) in October 2017. The vote will consist of successive rounds as needed, with the votes cast by secret ballot and each of the 27 member states having the same number of votes.

A final decision will be taken at the General Affairs Council and announced 20 November 2017.

The assessment will be based on six criteria including:

  • operationality guarantees (the availability of appropriate offices),
  • location accessibility (which includes the frequency and duration of flight connections),
  • schools for EMA staffers' children (including the availability of multi-lingual schools),
  • access to the labor market and health care for staffers' families, business continuity (to maintain and attract highly qualified staff) and
  • geographical spread.

In addition to the release of the applications, EMA said Tuesday that it will temporarily suspend several activities as part of its business continuity plan:

  • the development of the European Medicines Web Portal, a new publicly-available online information source on all medicines marketed in the EU;
  • EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorisation requests for human and veterinary medicines in a secure and efficient way;
  • the development of a transparency roadmap for EMA that lays out future transparency measures of the Agency; and
  • participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.

Quelle:

EMA: Offers to host the EMA

RAPS: 19 European Cities Vie to Host EMA Headquarters

Comments
No comment has yet been written about this news.
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (yearly subscription)