Legal and Regulatory Guide to EU’s New Pharmacovigilance Regulations Understanding the Implications and Nuances to Assure Compliance
Product Details
An FDAnews
Webinar Rebroadcast
On July 2, 2012, the European pharmaceutical industry will change forever. The EU has published what has been described as the largest transformation covering pharmacovigilance in more than a decade.
If you’re a marketing authorization holder (MAH) you’ll need to comply. Will you be ready?
With less than a month to go to the deadline, act now to register for this comprehensive webinar that will provide numerous, practical implementation strategies.
Here’s just a few of the new requirements you and your staff will be dealing with in the next 30 days and beyond:
-
The formation and creation of a new pharmacovigilance risk assessment committee (PRAC). Similar to the US’s open advisory committees, these groups will be transparent forums to discuss a product’s safety profile.
-
Say goodbye to DDPS (detailed description of pharmacovigilance systems) and hello to PSMFs (pharmacovigilance system master file). All MAHs will need to create PSMFs and continuously update them.
-
Enhanced monitoring of RMPs to assure compliance with requirements based on a product’s marketing authorization.
Here’s what our satisfied registrants had to say… “Speaker was very good… she offered insights based on past experience” “Presenter very good, appreciated that she would also provide her opinion and share her experience” “I liked that the speaker tried to simplify a pretty complex process” “Excellent presentation” |
-
Spread the word — the new regulations require MAHs to inform international regulatory bodies of safety related issues BEFORE — or at the same time — an MAH makes public disclosure of pharmacovigilance concerns.
-
MAHs shall record all suspected adverse reactions which are brought to their attention and shall ensure that those reports are accessible at a single point (including reports from post-authorization studies).
-
Signal detection is everyone’s priority — the new legislation expects the EMA and country officials to monitor the Eudravigilance database and alert members and MAHs to emerging safety signals. MAHs are obliged to evaluate all pharmacovigilance information and take appropriate measures as necessary.
-
The PASS is the future — authorities may require the MAH to submit the protocol and progress reports to member states for Post Authorization Safety Studies (PASS) in which the study is conducted. The new legislation also states that the final study reports should be sent to these member states within 12 months of the end of data collection.
-
Share and share alike — EU competent authorities and the EMA are expected to increase cooperation and sharing of information and resources related to pharmacovigilance inspections. Plus, inspectors will have the right to inspect the premises, records, documents and the PSMF of MAHs or any firms employed by the MAH to perform pharmacovigilance.
-
Internet sharing of information — regulatory agencies now have greater authority to share information with the public on safety information and general MAH information.
Mark your calendar for Thursday, June 21, when we’ll rebroadcast Elisabethann Wright’s highly praised webinar (this 90-minute webinar was originally hosted by FDAnews hosted on March 20, 2012). The focus isn’t on theory, but on real-world advice you can use immediately to build your EU pharmacovigilance program now — without hitting hot buttons that trigger problems from international regulatory authorities.
Register now to meet regulatory responsibilities and seize a competitive advantage against your competitors who might struggle in complying with these extensive regulations.
A flexible fit for your busy schedule
The Legal and Regulatory Guide to EU’s New Pharmacovigilance Regulations webinar is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Regulatory and medical affairs, compliance officers and corporate counsel will all benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget.
You pay one single low registration fee per facility, regardless of how many participate. So spread the word to your team!