Heike Volkmer

Company: Volkmer & Burt Consulting Team

Heike has almost 30 years of experience in national and international regulatory affairs, with specialist expertise in the European centralised procedure for biotechnologically-derived medicinal products. During this time, Heike has contributed to the successful approval of several biological and biotechnological products, including one of the first biosimilar medicines. Over the years, Heike has established a large number of personal contacts with representatives of the national EU authorities, the EMEA, CDER, CBER, TGA, and various other international agencies. She is a recognised expert for regulatory strategy and has authored or co-authored a number of CMC Expert Reports (Quality Overall Summaries). Since October 2000, Heike is Managing Partner of the VBC Team, a position she shares with her long-standing colleague, Tony Burt.