RA management

Ineke Jonker-Hoogerkamp, PhD                                 
                                 

Ineke Jonker-Hoogerkamp has been educated in Pharmacy followed by a PhD in pharmacokinetics. She has over 20 years of regulatory experience with large multinational pharmaceutical companies and small start-ups including broad experience in the regulatory aspects of global drug development, market approval and regulatory life cycle management of medicinal products. As director of the division Regulatory Affairs, Ineke is heading a team of professionals focusing on Regulatory Support, Regulatory Consultancy, including regulatory advice with respect to global drug development, Regulatory IT and CMC and Program Management, both in The Netherlands and in Germany.

Christine Degeling, BSc
  

Christine Degeling has been educated in chemical engineering and chemical environmental sciences, specialized in environmental toxicology. She has completed a post-graduate diploma program in Regulatory Affairs. Christine has over 15 years of experience in both preparation and evaluation of global regulatory submissions. In addition she is highly experienced in regulatory strategy and regulatory submission procedures both in drug development and for marketed products. Christine is manager of competence center Regulatory Support with focus on RA documentation, hands-on support for all activities within an RA department and on post-approval regulatory strategy.

Iedo Beeksma, Msc

Iedo Beeksma has been educated in Molecular Sciences and Bioprocess Technology. He has over 15 years of experience in the biopharmaceutical industry. Iedo has experience in both senior line management as well as program and project management functions related to organizational change, drug development, technology transfers, (non)clinical and commercial manufacturing. Iedo also is manager of the competence center CMC & Program Management, which focuses on management of and participation in projects related to drug development (IDD, Integrated Drug Development), cell line development, process development and outsourcing management, including assessment and selection of CMOs/CROs.

Robert Schultz-Heienbrok, PhD

Robert Schultz-Heienbrok has been educated in medical biology, followed by a PhD in protein biochemistry. He has completed a post-graduate program in Regulatory Affairs and has over 7 years of practical experience in the field. Working both with multinational pharmaceutical companies and small start-ups, Robert has gained broad experience with international submission procedures and dossier requirements for regulatory compliance as well as new market approvals. As managing director of Xendo Deutschland GmbH, he focuses on two main topics: regulatory strategy of marketed products (MRP, line extensions, variations) and regulatory consultancy for biopharmaceutical developments.