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Drug development is a multi-step process that involves a number of opportunities and requirements for interaction with regulatory authorities. Contact with regulators spans from the design and approval of clinical trials, use of scientific advice and other support programs during development, definition of potential orphan status and pediatric development, to specific aspects of advanced therapy products, different ways of gaining approval and postmarketing activities and commitments. Once a drug is approved, negotiations on reimbursement and pricing are necessary for effectively bringing it to market.
This workshop will address the various regulatory steps, explain the role of the European regulator not only as being a gatekeeper but also as an enabler supporting successful development, marketing authorization and market access. Both established approaches and specific new ones provided by the European regulatory network will be presented and discussed based on anonymized examples and discussion of practical cases and questions contributed by workshop attendees.
Pricing Amounts & Deadlines
Early Bird $400.00 Member | $500.00 Nonmember
8/15/2020 – September 7, 2020: Regular $600.00 Member | $500.00 Nonmember
Click here to download the agenda
Matthias Dormeyer is the Managing Director of MDC RegAffairs GmbH, a service provider in the fields of regulatory affairs.
In his work he has focused on designation, development and authorization of orphan drugs in the EU and US. Another area of expertise are paediatric drugs (including drafting and submission of Paediatric Investigations Plans (PIPs) and Request for Waiver) and management of marketing authorization applications under the centralized procedure. His expertise comprises small molecules, protein drugs as well as advance therapies for the treatment of a wide variety of diseases including for example cancer, autoimmune diseases, ophthalmological conditions, or infectious diseases.
After finishing his doctorate he worked at Knoll AG (now Abbott) in the field of early ADME. In January 2000 he joined 4SC AG, a biotech in Martinsried/Munich. His initial assignment was to set up to biological department and screening facilities. He then moved into project management and was among other responsible for the transition of projects from research to development and non-clinical and early clinical development of 4SC’s pipeline projects. He started his career as independent consultant and service provider after he left 4SC in 2006. In 2009 and he founded MDC RegAffairs GmbH.
Matthias Dormeyer is a chemist by training and holds a PhD in biochemistry as well as a Master in Drug Regulatory Affairs (MDRA).
Sabine Haubenreisser, MSc, PhD, is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators.
She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.
Sabine gained her Masters in Pharmaceutical Science and her PhD in Pharmacology from the Goethe-Universität in Frankfurt. She also holds a certificate in Epidemiology from the London School of Hygiene and Tropical Medicine.
Karl-Heinz Huemer, PhD MD,
medical assessor at the Austrian Medicines & Medical Devices Agency, Vienna / Austria
delegate to SAWP (Scientific Advice Working Party) and PDCO (Paediatric Committee) at EMA (European Medicines Agency), London / UK
for a more detailed CV please refer to the European Medicines Agency homepage https://www.ema.europa.eu/sites/default/files/ContactsAndExperts_CVs_and_DOIs/huemerk_CV_en.pdf
Prof. Andrea Laslop, MD, joined the Austrian Federal Office for Safety in Health Care in 2006. Within the business unit Austrian Medicines and Medical Devices Agency she is head of the Scientific Office, which focusses on centralised European procedures during drug development, marketing authorisation and life-cycle management. Since 2003 she is a member of the European Medicines Agency Scientific Advice Working Party and since 2007 of the Committee for Human Medicinal Products.
Prior to this Andrea Laslop worked as professor of pharmacology and toxicology at the Medical University of Innsbruck, Austria, where she had earned her degree as medical doctor with subsequent specialization in pharmacology and toxicology.
Jan Mueller-Berghaus M.D. is paediatrician by training and joined the Paul-Ehrlich-Institut as clinical expert in 2005. The Paul-Ehrlich-Institut is the German Federal Agency for Vaccines and Biomedicines and is actively participating in all aspects of German and European marketing authorisation as well as clinical trial authorisation. He is currently the German member of the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) and in 2017 he was re-elected as co-opted member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
María Concepción Prieto Yerro, MD, PhD, with speciality in Clinical Pharmacology. Maria works at the Spanish Agency for Medicines and Medical Devices (AEMPS). In 2001, Maria joined the AEMPS dedicated to the regulation of medicinal products. In 2006, Maria became representative for Spain at the Committee for Medicinal Products for Human Use (CHMP). As CHMP member, Maria is responsible for the assessment of a number of rapporteurships every year, actively contributing to the activities of the European system. Maria represents the Patients and Consumer Working Party (PCWP) at EMA as representative from the CHMP.
Maria’s goal is to promote the participation of patients in the development and authorization of medicines. Maria is a member of the Spanish National Board of Medicine.
Bjørn Oddvar Strøm studied pharmacy and neuroscience at Oslo University from which he has a PhD in molecular neurobiology, focusing on intercellular signaling, he is working as Senior Scientific Advisor for the Norwegian Medicines Agency (NoMA). His role within NoMA involves working at the intersection of regulatory and HTA work, a unique perspective due to the structure of the Norwegian Agency. His main tasks include clinical assessments, both for HTA and regulatory purposes, as well as scientific advice. He also participates in the Nordic voluntary co-operation FINOSE and the EUNetHTA early dialogue working party.
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