Gerard Farmer, PhD, Regulatory Affairs
Gerard Farmer is Director of Regulatory Affairs since June 2011. Dr Farmer started his career as an immunology scientist and became International Regulatory Affairs Manager at Hoffman-La Roche in 1989. In 1992, Gerard Farmer became VP Corporate Regulatory Affairs at Ares Serono International, a position which he held until 1998, he then joined Biolitec Pharma as Director of Regulatory Affairs and since 2003, is an independent regulatory consultant with his company Alfomec in Basel. Along these years, Gerard Farmer has achieved 16 major product approvals in the USA and European Union and overseen 14 biotechnological developments, has experience of more than 80 CHMP procedures and participated in more than 90 meetings with European national authorities, EMEA, CHMP, and FDA covering issues from pre-Phase I to oral explanations, appeals and post approval commitments. Mr Farmer achieved more than 500 submissions in the USA and EU covering IND, IMPD, MAA, PLA and NDA submissions, amendments and variations, Orphan Drug applications, Centralised Procedures, National Applications, Mutual Recognition procedures and Post Approval variations.