Pharmacovigilance only occasionally requires the assistance of a lawyer, however, legal problems that may arise in this area are generally very difficult.
Our Law Firm has experience in solving dilemmas related to PhV, in particular in the field of procedures, outsourcing contracts, performing the duties of conducting safety or effectiveness tests once the product is marketed (PASS, PAES), as well as the course and holding positions within the so-called referral proceedings before the CHMP, EMA and the European Commission.