It’s already Christmas !!

As we are nearing the festive season in our part of the world, I wanted to make a small present to my colleagues in the Pharmacovigilance community…

I agree that this is not a very sexy present. Not something that you put on your wish list or that you would enjoy with your friends or family: I am only offering you a free peek into the latest issue of Safety Observer, the leading Regulatory Monitoring Solution for Pharmacovigilance Professionals.

You can consult other free samples on the website but I am very aware that the value of the contents of each issue wears off with time. This is why I am offering you access to the full December issue for free !

Just click the picture to download your free copy and feel free to share with your contacts:

This issue was distributed to subscribers today: Thursday 07-Dec-2017. I hope you enjoy it and I would be delighted if this fresh issue can convince you of the value the service can bring to your organisation in the frame of your Regulatory Intelligence activities.

Please visit the website or contact me if you would like to know more about the service. Please also subscribe to the Free Monthly Updates and you will receive a discount code to be used against your first purchase through the website.

Thierry Hamard is a Pharmacist with more than 12 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

Signal Detection with EudraVigilance: A brief overview of changes to come

This post provides a short overview of the upcoming changes in relation to Signal Detection in Europe and the resulting new obligations for Marketing Authorisation Holders.

EMA issues revised GVP Module IX on Signal Management (12-Oct-2017)

The EMA has now released the final version of GVP Module IX on Signal Management (Rev. 1), which includes guidance for the continuous monitoring of EudraVigilance data by Marketing Authorisation Holders (MAHs).

It specifies that EudraVigilance data should be reviewed with a frequency proportionate to the identified risk, at least every 6 months. Module IX also describes the procedural options available to MAHs in the event they identify validated signals.

Methodological aspects of signal detection are now addressed separately in a new Addendum I, which introduces the concept of Designated Medical Events (DMEs). The list of DMEs contains 62 MedDRA Preferred Terms corresponding to serious medical concepts often causally associated with drugs across multiple classes.

EMA provides information on Signal Detection Pilot (27-Oct-2017)

As described in GVP Module IX, MAHs have a requirement to continuously monitor EudraVigilance data and inform the EMA and EU National Competent Authorities of validated signals detected in the database. This will become possible with the implementation of the new EudraVigilance system on 22-Nov-2017.

The EMA has defined transitional arrangements to streamline the implementation of this new process. During a pilot period of one year, only MAHs whose active substances are included in the list of medicines under additional monitoring will be subject to the new requirements.

This will apply from 22-Feb-2018, allowing 3 months for MAHs to become familiar with the new EudraVigilance system and adapt their processes. Other MAHs will have access to EudraVigilance data but the new obligations will not apply to them until the pilot is completed and the EMA defines the next phase of implementation.

Explore the topic further: Free Webinar !

Essjay Solutions Ltd will hold a Free Webinar on Signal Detection and EudraVigilance, which will provide an overview of these changes and offer some advice on how to manage them. This webinar will take place on 21-Nov-2017 at 11:00 AM GMT.

→  Link to EMA GVP Page

→  Link to EMA Signal Management Page (includes DME List)

→  Link to Essjay Solutions Webinar Registration Page

Thierry Hamard is a Pharmacist with more than 12 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

EMA issues go-live plan for the new EudraVigilance

The implementation of the new EudraVigilance system requires the migration of more than 11 million cases from the current database, which will be completed from 08 to 21-Nov-2017 when some functionalities of the system will be unavailable. The electronic submissions of data on medicines (Article 57) will be unavailable whereas the electronic reporting of ICSRs by National Competent Authorities (NCAs), Marketing Authorisation Holders (MAHs) and Sponsors of Clinical Trials (Sponsors) will be disrupted.

The go-live plan published by the EMA describes the alternative reporting arrangements during the cutover period, and three options are presented separately for Clinical Trial SUSARs and Post-marketing ICSRs:

• Option 1: The submission is stopped. This applies to EudraVigilance but also to a list of NCAs, some of which will stop sending/receiving cases as early as 04-Nov-2017.
• Option 2: The MAH/Sponsor has to follow alternative arrangements (e.g. fax or email) for submission to NCAs during the cutover period.
• Option 3: No change to current arrangements. The MAH/Sponsor continues with the electronic submission of NCAs, which applies in the UK (MHRA) and Germany (BfArM and PEI). Specifically for SUSARs, Option 3 also applies to NCAs that do not currently accept E2B reports (e.g. France) and Sponsors should continue with the current reporting method (e.g. email or web portal).

Following the launch of the new EudraVigilance system on 22-Nov-2017, all reports that could not be submitted electronically during the cutover period will need to be submitted within 2 EMA business days following the go-live of EudraVigilance, i.e. by 24-Nov-2017.

Regarding Post-Marketing ICSRs routinely sent by NCAs to MAHs, the MAHs will need to use EVWEB functionalities to download the reports submitted by NCAs to EudraVigilance and the corresponding ICSRs will be available for download as of 23-Nov-2017.

The Medical literature monitoring (MLM) by the EMA will continue during the cutover period but the screening results will only become available to MAHs in the restricted area of EudraVigilance on 22-Nov-2017. The resulting valid cases will be entered from 20 to 30-Nov-2017 and the corresponding ICSRs will again start to become available for download by MAHs as of 23-Nov-2017.

In addition to the go-live plan, the EMA has published a short Technical Note that describes the impact of the planned downtime on other IT systems and provides corresponding instructions. This concerns for example submission to the PSUR Repository and EudraCT database.

→    Link to EMA News Release

→    Link to EudraVigilance Page

→    Direct link to EudraVigilance Go-Live Plan

→    Direct link to Technical Note

Thierry Hamard is a Pharmacist with more than 12 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.