Dr. Heike Volkmer
Heike has nearly 30 years of experience in national and international regulatory affairs, with specialist expertise in the US and European centralized procedure for biotechnologically-derived medicinal products. During this time, Heike has contributed to the successful approval of many biological and biotechnological products, including one of the first biosimilar medicines. Most of the EU submissions were part of a global strategy involving parallel approvals in the US, Australia, Switzerland, Canada, Korea, Japan, South America and other parts of the world. Over the years, Heike has thus established a large number of personal contacts with representatives of the national EU authorities, the EMA, 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).