With over 30 years’ experience in the biopharmaceutical and pharmaceutical industry, Dr. Ramzan is the principal regulatory affairs consultant at Woodley BioReg. He is an expert in the development of drugs, biologics, and medical devices / IVDs — supporting a wide range of manufacturers globally.
This edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing impact of the EU Medical Devices Regulation (MDR) on clinical studies and data.
This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.