News -

PSMF establishment and maintenance, business as usual?

Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).

The PSMF comprises a range of annexes supported by a main document that, in its entirety, encapsulates the respective MAHs approach to continuous monitoring of a given product’s risk-benefit balance.

But how do companies ensure that the PSMF and corresponding annexes are updated and successfully reflect the company’s pharmacovigilance system? And how do you as an organisation successfully implement and maintain a PSMF without the need for additional resources?


Related links

Topics

Categories

Contacts

Lars B. Petersen

Press contact Senior Vice President Communications, Marketing & Commercial Excellence +45 3075 9102

Related media

Related content

Make the most of serialization

Change is afoot for pharmaceutical companies, with new serialisation legislation on the agenda. To help stem the problem of drug counterfeiting, they will be required to adopt a unique serial number labelling system and adapt their business processes accordingly. How can companies derive real business value from the investments they are now required to make?

BI tool for smooth submission planning and execution

Regulatory approval for pharmaceutical products can be difficult to obtain, not least because the submission process is often slow and prone to errors. Thomas Svendsen and Peter Noes of NNIT tell World Pharmaceutical Frontiers how regulatory teams can use a business intelligence tool to monitor submission status and hasten time to market.

ISO IDMP is the next after xEVMPD

ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. ISO IDMP will transform your regulatory IT strategy.

Global Tracking Regulations Present Challenges and Benefits

Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization.

NNIT is ready with SAP's new integration platform

The latest version of the integration tool SAP PO is a pure Java solution that runs faster and provides new opportunities for communication with EDI systems. The new version of SAP Process Orchestration is both smarter and faster than its predecessor. Companies must consider a number of aspects before deciding on an upgrade, advises SAP expert Peter Kreiner from NNIT.

Are you ready for ISO IDMP?

Are you ready for ISO IDMP?

Following the implementation of XEVMPD, new legislation, based on five new ISO IDMP standards, is due to come into force in 2016. Rune Ringsholm Bergendorff, advanced business consultant at NNIT, explains how pharmaceutical companies will need to adapt business processes across the whole organisation.

Enter your email address to follow NNIT News

When you choose to create a user account and follow a newsroom your personal data will be used by us and the owner of the newsroom, for you to receive news and updates according to your subscription settings.

To learn more about this, please read our Privacy Policy, which applies to our use of your personal data, and our Privacy Policy for Contacts, which applies to the use of your personal data by the owner of the newsroom you follow.

Please note that our Terms of Use apply to all use of our services.

You can withdraw your consent at any time by unsubscribing or deleting your account.
Check your inbox

Email sent to __email__. Click the link there to follow NNIT News.

Okay