Risk management plan information day
This information day will update participants on the Agency's medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety specification for biologicals with a special focus on biosimilars, so that only risks that are important for risk management and relevant for the benefit-risk of the product are included in the RMP. The Agency will provide updates on risk management aspects of the new good pharmacovigilance practice (GVP) guidance on special populations such as children and elderly. Other topics will include risk communication and patients' access to information on the safety of medicines.