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Emanuel Kuhn
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Life Sciences Topics Current industry issues — compact and comprehensible

Real World Data

Real World Data —
May 11, 2020

In 2017, we posted an article on RWD for the first time. Three years later, what we wrote at the time is still very much valid. You don’t need to call us prophets — but you’re welcome to call us experts. Progress in health care depends on ... More
EU-Hub Falsified Medicines Directive

Falsified Medicines Directive
October 10, 2019

The American Food and Drug Administration estimates that ten percent of all medications worldwide are falsified. With the Falsified Medicines Directive (FMD) 2011/62/EU, the European Union has taken a stand against falsification to protect ... More
IDMP Update Jahr 2017 / 2018

IDMP Update 2017 / 2018
April 5, 2018

Though no binding specifications have been issued by the European Medicines Agency (EMA) for when the IDMP (Identification of Medicinal Products) regulation has to be implemented, quite a bit has happened in the area over the past few months. ... More
MDSAP – Medical Device Single Audit Program

MDSAP – Medical Device Single Audit Program
January 22, 2018

The stated aim of the Medical Device Single Audit Program (MDSAP), which officially took effect in June 2017, is to reduce audit effort for quality management systems (QMS) for authorities as well as for medical device companies. The ... More
EU-FDA Mutual Recognition Agreement (MRA)

EU-FDA Mutual Recognition Agreement (MRA) has come into force
December 5, 2017

On November 1, 2017 the Mutual Recognition Agreement (MRA) between the EU and US came into force. It defines the future cooperation between the FDA and EU regulatory authorities and stipulates mutual recognition of audits of pharmaceutical ... More
Success Story Vifor Pharma

Efficient Quality Reporting for Vifor Pharma
October 31, 2017

Price pressure and tough competition are driving pharmaceutical companies to higher quality and continuous improvement. The quality management department of Vifor Pharma is making its own contribution and prescribed a slimming diet to its own ... More
IDMP (Identification of Medicinal Products)

IDMP (Identification of Medicinal Products)
June 22, 2017

Background In June 2012, with the aim of improving EU-wide pharmacovigilance, the EU Parliament approved Regulation No. 520/2012 – also known as IDMP (Identification of Medicinal Products). It calls on the EMA to provide a central register of ... More
General Data Protection Regulation (EU GDPR)

General Data Protection Regulation (EU GDPR)
January 31, 2017

In May 2018, the EU’s new General Data Protection Regulation (GDPR) will enter into force and replace former national legislation. This will affect not only organizations in the EU’S member states, but all organizations worldwide that collect or ... More
Falsified Medicines

Falsified Medicines
November 23, 2016

The EU GMP Annex 16 has been revised in order to reduce the risk of undiscovered sub-standard medicines in the supply chain. Using the example of one of our customers we present the guideline’s requirements and show how to fulfill these in ... More
Project Health Check – A Project Audit

Project Health Check – A Project Audit
August 17, 2016

What is the difference between the Berlin-Brandenburg Airport and the railway tunnel through the Gotthard? Or in other words, what have the people in charge of the construction project done better to not only complete their project successfully, ... More
ISO 13485:2016 Medical Devices Management

ISO 13485:2016 – New requirements for the medical devices sector
July 20, 2016

The production of medical devices is highly regulated, which is reflected particularly in EU regulations and standards. If one of these standards is updated in response to rapid progress, it is crucial to react fast and to implement the required ... More
ARCONDIS transparency EFPIA Disclosure Code

EFPIA Disclosure Code
February 19, 2016

In summer 2016 the EFPIA Disclosure Code (European Federation of Pharmaceutical Industries and Associations) will come into force. It obliges all companies in the pharmaceutical industry to disclose nonmonetary benefits, which have been granted ... More
Change and Risk Management in Continuous Process Validation

Change and Risk Management in Continuous Process Validation
February 19, 2016

… is a topic with plenty of potential with respect to Annex 15 that was recently enacted. The pharmaceutical industry has been speaking about this hot topic for months. But what makes the enactment of the new European guideline, Annex 15, so ... More
Big Data Pharma & Life Sciences

Big Data — a curse or a blessing?
February 16, 2016

The high-content microscope for the 4D imaging of our customers produces data volumes of up to one terabyte in a few hours. It is a symbol of the explosion of data that companies have been confronted with for several years. No weakening of this ... More
IT Services in the Cloud

GxP in the Cloud. Quo vadis?
February 1, 2016

By 2017, 77% of German companies will use a hybrid cloud, according to the result of a study by the IDC at the end of 2015. It is hardly surprising since the technology promises flexibility and cost efficiency. For the question is also ... More