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 email@example.com 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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to firstname.lastname@example.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 29 July 2015 | By Michael Mezher
In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS).
Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines.
The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate robust data." When giving scientific advice, EMA will answer questions given by a drugmaker "in light of the current scientific knowledge, based on documentation provided by the company."
EMA notes that its advice is "prospective in nature" and is meant to advise companies on strategic issues during development, and is not meant to pre-evaluate clinical data.
Once a drug is authorized, companies are required to conduct various types of postmarket surveillance to ensure their product's safety once on the market.
One way this is done is by conducting PASS. These studies are either non-imposed, meaning a company undertakes the study of its own volition, or imposed. An imposed PASS is usually carried out when a product is authorized to meet an urgent need before more thorough clinical studies can be completed, or by request of the Pharmacovigilance Risk Assessment Committee (PRAC).
Beginning July 2015, EMA is expanding its scientific advice procedure to include scientific advice for designing PASS.
Both SAWP and PRAC will be involved in the pilot, and all advice will be endorsed by PRAC before being issued.
EMA says the pilot will primarily focus on non-imposed PASS, and expects the advice will help companies design higher quality safety studies that will "provide useful information on a medicine in a real-life setting."
EMA says companies participating in the pilot can benefit from:
"a strengthened PRAC-SAWP interactiona lifecycle approach to medicines advice with integrated advice on all aspects of medicines development from involved Committeessupport for proactive pharmacovigilance planningadvice at an early or late stage of the protocol developmenttargeted advice on key issuesa well-defined procedural timetablea pre-submission interaction with Agency secretariat to consider suitability and validity of the dossiera face to face meeting with involved regulators during the procedureengagement with patient representativesoptions to include other stakeholders such as HTAs or FDA further supporting optimised evidence generationthe possibility of seeking follow-up advice"
The pilot is entirely voluntary and will run for one year. EMA has also updated its questions and answers guide for scientific advice to reflect the pilot and has published a letter of intent for companies wishing to participate in the pilot to complete.
EMA, PASS Q&A (Question 10)
Tags: Post-authorization safety studies, PASS, SAWP, PRAC