Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 21 September 2017 | By Zachary Brennan
Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable.
"While we acknowledge the need to avoid and manage any risk of bias, experience over the years shows that such risk can be managed by having in place the necessary safeguards and I can assure you that the Agency guarantees adequate implementation of such safeguards," Rasi said in a letter sent 29 August. "These include a strong policy for managing conflict of interests, a rigorous and independent process for evaluation of medicines and an unparalleled level of transparency of the Agency's operations."
The letter from EMA was sent following Ombudsman Emily O'Reilly's inquiry from July in which she raised concerns about EMA's pre-submission meetings with sponsors influencing decisions about approvals of marketing authorizations.
But Rasi stressed that EMA is meeting its legal obligations with the meetings and that it separates the earlier stage advice for industry from a final decision on a product.
"No single person has the final say on a medicine's approval. Our Committees issue scientific recommendations based on extensive peer-review and discussions amongst approximately 30 committee members. The assessment is also supported by a wide range of independent experts, including patients, from around the EU; all of these bring their knowledge, experience and views into the decision-making process," he wrote.
O'Reilly raised concerns about a press release that had been issued by an unnamed company that played up the company's interactions with EMA (a tactic frequently seen in the US), reporting it had received indications of support for its application. O'Reilly said the public could see this as evidence of bias and wants EMA to do more to allay such perceptions.
Rasi responded: "The potential public perception of bias is a concern which the Agency has always taken extremely seriously. The Agency has strong links with civil society, embedded in its day-to-day functioning and its governing structure. EMA has been at the forefront in Europe in developing interactions with patients, consumers and healthcare professionals in a way that allows them to engage in the work of the Agency at all levels of its operations, from the Management Board, to fully participating in the scientific evaluation through its Scientific Committees, Working Parties and Scientific Advisory Groups."
Tags: EU ombudsman, early regulator engagement, pre-submission meetings