Pharmacovigilance: 5 Predictions for 2013
Wondering what 2013 might look like for Pharmacovigilance, here are some predictions that can help you with better planning…
Post Authorization Safety studies
Over the last few years, spontaneous passive reporting has been the cornerstone of pharmacovigilance, however, the role of post-authorization safety studies and stimulated reporting is predicted to increase tremendously. Although spontaneous reporting will continue to play a central role, planned post-marketing studies will be helpful in the early identification of new adverse reactions.
New EU Regulations
Since 2009, EU authorities have been working hard to put together new EU regulations. Although, new EU regulations came into effect in 2012, several aspects of these will be implemented in 2013, thus keeping pharma companies and their outsourced partners extremely busy.
Some of these include a new template for PSURs, a new EURD list, a new format for RMPs and signal detection in EudraVigilance. Further modules of safety communication, public participation in Pharmacovigilance, international cooperation and risk minimization measures are planned to be released in various quarters of 2013.
Public Participation in Pharmacovigilance
Reporting by patients and consumers will increase consistently and they are expected to play a greater role in the early identification of new adverse reactions.
The growing importance of the public- regulator partnership is also underlined by the new EU regulation which requires that companies also submit consumer reports (not medically confirmed) on an expedited basis.
EMA is also planning to release module XI- Public Participation in Pharmacovigilance in the second quarter of 2013. Emphasis will be on 3-way communication, where companies will also be expected to implement risk minimization programs that include direct safety communications to consumers along with communication to health care practitioners responsible for prescribing, dispensing and administering.
Spending on Pharmacovigilance
Just like previous years, the scope of pharmacovigilance and pharmacovigilance activities will continue to increase and so will the spending on pharmacovigilance. Spending on pharmacovigilance will increase both in regulated as well as semi-regulated markets, however, the trends will be different.
In regulated markets, the focus will be on risk management planning including risk minimization and additional pharmacovigilance activities, whereas semi-regulated markets will continue to focus on improving the compliance with routine pharmacovigilance activities.
Systematic learning of Pharmacovigilance
With the implementation of the EU2P program and several other certificate courses, learning of pharmacovigilance is expected to be more streamlined. This is expected to bring efficiency in pharmacovigilance activities, otherwise directed at regulatory compliance. Systematic learning of pharmacovigilance is the requirement of the day, and I am hoping to see some more courses well-equipped to provide systematic training in Pharmacovigilance as a result.
We will continue to monitor the developments in pharmacovigilance to report to you the latest activities and trends in pharmacovigilance. Keep Reading…
You Should Check Out:
Pharma 2020: Which path will you take?
November 22, 2012
EU Product Launch – Key Considerations for Successful Niche and Orphan Drug Product Launches
February 9, 2012
Adverse Event Reporting Online Training Course 2011
August 3, 2011