1. Bakker E, Mol PGM, Nabais J, Vetter T, Kretzler M, Nolan JJ, Mayer G, Sundgren AK, Heerspink HJL, Schiel A, de Vries ST, Gomez MF, Schulze F, de Zeeuw D, Pena MJ; BEAt-DKD Consortium. Perspectives on a Way Forward to Implementation of Precision Medicine in Patients With Diabetic Kidney Disease; Results of a Stakeholder Consensus-Building Meeting. Front Pharmacol. 2021 May 4.
  1. van den Biggelaar RHGA, Hoefnagel MHN, Vandebriel RJ, Sloots A, Hendriksen CFM, van Eden W, Rutten VPMG, Jansen CA. Overcoming scientific barriers in the transition from in vivo to non-animal batch testing of human and veterinary vaccines. Expert Rev Vaccines. 2021 Sep 22
  1. Bloem LT, Karomi M, Hoekman J, van der Elst ME, Leufkens HGM, Klungel OH, Mantel-Teeuwisse AK. Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks. Expert Opin Drug Saf. 2021 Jul 15.
  1. Bloem LT, Vreman RA, Peeters NWL, Hoekman J, van der Elst ME, Leufkens HGM, Klungel OH, Goettsch WG, Mantel-Teeuwisse AK. Associations Between Uncertainties Identified by the European Medicines Agency and National Decision-making on Reimbursement by HTA Agencies. Clin Transl Sci. 2021 Mar 30.
  1. Blume Hh, Mehta M, Beuerle G, Dorantes A, Hempel G, Jiang W, Kovar A, Lee J, Potthast H, Schug B, Seidlitz A, Tampal N, Y-C Tsang, Walstab J, Welink J. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference. Eur J Pharm Sci. 2021 Sep 1
  1. Butler D, Vucic K, Straus S, Cupelli A, Micallef B, Serracino-Inglott A, Borg JJ. Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU. Expert Opin Drug Saf. 2021 Apr 22.
  1. Correia Pinheiro L, Giezen TJ, Wolff-Holz E, Weise M, Laslop A, Hidalgo-Simon A. Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions. Clin Pharmacol Ther. 2021 Sep 2.
  1. Dekker MJHJ, Stolk P, Pasmooij AMG. The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency. Front Med (Lausanne). 2021 Jul 1.
  1. Dekker MJHJ, de Vries ST, Versantvoort CHM, Drost-van Velze EGE, Bhatt M, van Meer PJK, Havinga IK, Gispen-de Wied CC, Mol PGM. Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency. Front Med (Lausanne). 2021 Mar 11.
  1. Delgado J, Zienowicz M, van Hennik PB, Moreau A, Gisselbrecht C, Enzmann H, Pignatti F. The European Medicines Agency Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma. Oncologist. 2021 Jul 2.
  1. Duijndam B, Goudriaan A, van den Hoorn T, van der Stel W, Le Dévédec S, Bouwman P, van der Laan JW, van de Water B. Physiologically Relevant Estrogen Receptor Alpha Pathway Reporters for Single-Cell Imaging-Based Carcinogenic Hazard Assessment of Estrogenic Compounds. Toxicol Sci. 2021 May 27.
  1. Ghalandari N, Kemper E, Crijns IH, Wolbink G, Rispens T, Smeele HT, Dolhain RJ. Analysing cord blood levels of TNF inhibitors to validate the EULAR points to consider for TNF inhibitor use during pregnancy. Ann Rheum Dis. 2021 Sep 7
  1. Gülave B, Hew MN, de Groot JS, Rodwell L, Teerenstra S, Fabriek BO. High body mass index and pre-existing autoimmune disease are associated with an increased risk of immune-related adverse events in cancer patients treated with PD-(L)1 inhibitors across different solid tumors. ESMO Open. 2021 Apr 19.
  1. Helfer BM, Ponomarev V, Patrick PS, Blower PJ, Feitel A, Fruhwirth GO, Jackman S, Pereira Mouriès L, Park MVDZ, Srinivas M, Stuckey DJ, Thu MS, van den Hoorn T, Herberts CA, Shingleton WD. Options for imaging cellular therapeutics in vivo: a multi-stakeholder perspective. Cytotherapy. 2021 Apr 5.
  1. van Hunsel F, de Jong E, Gross-Martirosyan L, Hoekman J. Signals from the Dutch national spontaneous reporting system: Characteristics and regulatory actions. Pharmacoepidemiol Drug Saf. 2021 Apr 11.
  1. De Jong AJ, Santa-Ana-Tellez Y, van Thiel GJMW, Zuidgeest MGP, Siiskonen SJ, Mistry D, de Boer A, Gardarsdottir H; Trials@Home Consortium. COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union. Clin Pharmacol Ther. 2021 Mar 5.
  1. Jonker CJ, de Vries ST, van den Berg HM, McGettigan P, Hoes AW, Mol PGM. Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders. Drug Saf. 2021 Jun 6.
  1. Koomen JV, Stevens J, Monster-Simons MH, Heerspink HJL, Mol PGM. A Review of the Dose Justification of Phase 3 Trials to Regulatory Authorities for Drugs Intended for the Treatment of Type 2 Diabetes in Europe. Front Pharmacol. 2021 Apr 28.
  1. Roldan Munoz S, Postmus D, de Vries ST, Arnardottir AH, Dolu İ, Hillege H, Mol PGM. Differences in Importance Attached to Drug Effects Between Patients With Type 2 Diabetes From the Netherlands and Turkey: A Preference Study. Front Pharmacol. 2021 Feb 25.
  1. Schneider MR, Oelgeschlaeger M, Burgdorf T, van Meer P, Theunissen P, Kienhuis AS, Piersma AH, Vandebriel RJ. Applicability of organ-on-chip systems in toxicology and pharmacology. Crit Rev Toxicol. 2021 Aug 31.
  1. Sheean ME, Naumann-Winter F, Capovilla G, Kalland ME, Malikova E, Mariz S, Matusevicius D, Nistico R, Schwarzer-Daum B, Tsigkos S, Tzogani K, Larsson K, Magrelli A, Stoyanova-Beninska V. Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective. Front. Med. (Lausanne), 27 August 2021.
  1. Tomeo F, Mariz S, Brunetta AL, Stoyanova-Beninska V, Penttila K, Magrelli A. Haemophilia, state of the art and new therapeutic opportunities, a regulatory perspective. Br J Clin Pharmacol. 2021 Mar 27.
  1. Tsigkos S, Mariz S, Sheean ME, Larsson K, Magrelli A, Stoyanova-Beninska V. Regulatory Standards in Orphan Medicinal Product Designation in the EU. Front Med (Lausanne), 2021 Jun 25.
  1. Vellinga R, Hannivoort LN, Koomen JV, Colin P, Absalom AR, Struys MMRF, Eleveld DJ. Clinical validation of pharmacokinetic/pharmacodynamic models for propofol infusion. Response to Br J Anaesth 2021: 126: e172-4. Br J Anaesth. 2021 Apr 29.
  1. de Vries ST, Denig P, Andrić A, Dimov Di Giusti M, Ptaszynska-Neophytou A, Härmark L, Mol PGM.  Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK. Drug Saf. 2021 Aug 8.