Hot topics

An overview of the latest conversations happening in the member only discussion rooms 

21 January 2017

Disaster recovery for medical information enquiries

We are looking at backup times for our medical information database to recover data following a problem at the main server site. Does anyone know if there are any industry norms / recommendations? We currently have 24 hour backup to a second sit...

21 January 2017

ICH E6(R2)

Has your organisation implemented ICH E6(R2) into either project risk-assessment; broader principles of quality risk management; and risk-based monitoring? Have any of your clinical trials been subject to inspection against the requirements of I...

21 January 2017

Serious ICSRs from outside of EU - expectedness when reporting in the EU

If we receive a serious unexpected ICSR from the US, should we ascertain expectedness against the EU SmPC before reporting or should we report using the expectedness provided from the US safety information? Many thanks. Log in to the Discus...

14 April 2016

EVMPD Bulk Update Tool

We have done a bulk update through the xEVMPD at EMA for all licences for one of our clients and we received back in the WEB Trader - Bulk update 56 folders (the system automatically divided the total number of licences in 56 lots). However, the...

14 April 2016

French imputability scores

Does anyone have any clear guidance on how to generate a French imputability score? I have a literature article (Therapie (2013): 68(2):69-76), but would like something that would be easy(?) to use by case processing Log in to the Disc...

14 April 2016

Out of hours call handling

Please can you advise how you manage out of hours calls with regard to whether you have a dedicated phone, and if so, whether you get additional payment for manning this phone OOH? Log in to the Discussion Forum in the Member Area...

20 April 2014

PIPA MI Standards Feedback

The PIPA Committee would welcome feedback on the MI Standards published last Autumn. Log in to the Discussion Forum in the Member Area of the website to view the latest updates for this topic

20 April 2014

Replacement of pharmaceutical product for patients visiting the UK

A PIPA member has posted an enquiry asking whether anyone has experience of helping patients visiting the UK to replace a pharmaceutical product prescribed in another country, which has been subject to a quality issue. Log in to the Di...

20 April 2014

Screening literature for ICSRs

A PIPA member has posted an enquiry regarding using a third party to screen literature databases for relevant articles to be reviewed for ICSRs or safety signals. Log in to the Discussion Forum in the Member Area of the website to...

10 September 2013

Scottish Medicines Consortium - comparator companies

A PIPA member has asked whether anyone has experience of ensuring they're classed by the SMC as a comparator company when they're undertaking an HTA? Log in to the Discussion Forum in the Member Area of the website to view the lat...