Regulatory Affairs and
CMC Conference

Head Global RAMACA Systems & Regulatory Operations
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Dr Bonertz heads the Clinical Trials Unit of a federal institution, which is responsible for the authorisation of vaccines and biomedical medicinal products. He is also actively involved in various national and international committees of the EMA and EDQM, which play a key role in shaping the regulatory framework for the authorisation of medicinal products in the European Union.

Dr. Axel Korth is a senior life sciences lawyer with experience both as an in-house legal counsel as well as in private practice. Axel Korth is currently working as Corporate Counsel at Biocon Biologics providing legal and compliance-related advice to Biocon's EU business operations. Prior to joining Biocon Biologics, Axel worked at as Assistant General Counsel at Shionogi and Senior Legal and Regulatory Affairs Advisor at EUCOPE representing the organization at the EC, EMA, HMA, CMDh and other fora with a focus on regulatory and legal affairs. Prior thereto, Axel worked as Head Legal DACH at Biogen with a focus on market access, pricing and reimbursement, general healthcare law and compliance, antitrust and competition, public policy and government affairs. Axel also worked in commercial legal roles as Head Legal MEA and Senior Legal Counsel WEMEA at Sandoz (Novartis group) and held positions of continuing seniority at international law firms Shearman & Sterling LLP and Taylor Wessing.

Regulatory Affairs Specialist as an APIC representative Ajda Podgorsek Berke, has a PhD in organic chemistry and more than 20 years of overall experiences in R&D area. For last 9 years, she has been working in Regulatory affairs in Sandoz, in field dedicated to API. Last five years she is highly involved and specialized in Mutagenic impurities topics, including Nitrosamines Risk assessments for APIs and drug products. She is currently chairing the APIC Task Force "Nitrosamines" and as such involved in discussions between APIC and other HAs (i.e. EMA, EDQM) and Industry Trade Associations (i.e. MfE) on topics related to mutagenic impurities & nitrosamines.

After studying pharmacy, Marcus Savsek worked in the development department of Madaus AG. Since 2001, he has been an assessor for the approval of chemically defined medicinal products and, since 2018, has been deputy head of department in the Neurology, Psychiatry and Ophthalmology Department at the Federal Institute for Drugs and Medical Devices in Bonn. For many years, he has been an expert and trainer on regulatory topics related to pharmaceutical quality and pharmacokinetics, has been involved in the preparation of relevant guidelines, and holds a lectureship at the University of Nicosia.

Department Regulatory Affairs, Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management Angela Schütz, MA is a regulatory service expert at Austrian Agency for Health and Food Safety, with more than twenty years of experience in lifecycle management and with new applications. She has a strong background in regulatory skills and expertise for new application. She is committed to always stay up to date and to implement procedures in partnership as quickly as possible. Angela Schütz has a Master's degree in "Leadership, Politics and Management" from the FH Campus Favoriten, Vienna and a discontinued degree in veterinary medicine in the final stage.

Senior Director from Sandoz as an APIC representative Veronika Schwarz is a Senior Director leading the API Registration team Austria at Sandoz. She brings over a decade of experience in regulatory affairs, having held various roles across regulatory affairs. Veronika holds a PHD degree in organic chemistry from the University of Innsbruck. She is currently an active member of the APIC Task Force on ICH M4Q and contributed to the development of a mock case for ICH M4Q(R2) from APIM perspective.