Documents

ESPT has decided, after his last board meeting in Rome (June 12th), to work more closely with the other European and International organizations. In this part, we will put documents that we endorse and documents to be discussed.

Gerard Siest

ESPT President

 

Endorsed by ESPT Board: P3G Draft #6 “International Code of Conduct of Genomic and Health-related Data sharing and EMA guideline

EMA Guidelines: “Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products” – To comment for July 15th.

EMA: Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies

Pharmacogenetic Allele Nomenclature: International Workgroup Recommendations for Test Result Reporting.

Kalman LV, Agúndez JA, Appell ML, Black JL, Bell GC, Boukouvala S, Bruckner C, Bruford E, Bruckner C, Caudle K, Coulthard S, Daly AK, Del Tredici AL, den Dunnen JT, Drozda K, Everts R, Flockhart D, Freimuth R, Gaedigk A, Hachad H, Hartshorne T, Ingelman-Sundberg M, Klein TE, Lauschke VM, Maglott DR, McLeod HL, McMillin GA, Meyer UA, Müller DJ, Nickerson DA, Oetting WS, Pacanowski M, Pratt VM, Relling MV, Roberts A, Rubinstein WS, Sangkuhl K, Schwab M, Scott SA, Sim SC, Thirumaran RK, Toji LH, Tyndale R, van Schaik RH, Whirl-Carrillo M, Yeo KJ, Zanger UM.

Clin Pharmacol Ther. 2015 Oct 19. doi: 10.1002/cpt.280.