– Overcoming challenges when moving from non-clinical to clinical
When: May 27th
Time: 10:00 to 11:30 CET
Place: Digital webinar
Going from non-clinical to clinical is no easy step. Join our free webinar on May 27th and listen to a few of our key experts from essential product development areas to talk about how to survive and minimize the early risks biotech companies face during the life-cycle of product development. We have a complete panel of experienced experts who will go through key elements to consider in the clinical development process.
This event is designed to help biotech companies in early development however, the content will also be helpful for the full life cycle of a product. View the agenda below to learn more.
* Please kindly note that this event is not for competitor service providers.
|9:45||The Meeting opens up for early login|
|10:00||Introduction of team|
|10:05||Factors to consider when selecting a manufacturer.
The value of a GMP audit
Hilde Ringstad, Director Quality Assurance and Compliance
Crucial CMC regulatory compliance strategy In early biotech
|Lone Dyrby, Regulatory Director – Denmark|
Pipeline strategy; Clinical trials and their relative value inflection points
|Austin Smith, VP Clinical Development, Oncology specialist|
The value of Scientific advice
|Marie Moores, EVP Clinical Operations|
|10:45||Biostatisticians early in the design||
Christina Ehrenkrona, Senior Biostatistician
|10:55||The importance of proper data handling||
Mario Baban, EDC Group Manager
|11:05||Clinical Trial Safety||
Tina Elberling, Director of International Safety Operations
About our speakers
Director Quality Assurance and Compliance
Hilde joined LINK Medical in 2018 and holds a MSc in pharmacy. She has a background in the pharmaceutical industry and wholesale of medicinal products, where she has held different roles within management and quality assurance, e.g. Qualified Person and Responsible Person. She has also had several positions with health authorities, last as head of inspection at the Norwegian Medicines Agency.
Regulatory Director – Denmark
Lone has over 20 years’ experience within Regulatory CMC, working extensively within biologics. Lone has a MSc in pharmacy and a diploma in leadership (bachelor level). Lone has been part of the Danish team since in October 2020. Prior to that, she had various positions in the pharmaceutical industry as Regulatory CMC specialist and Head of Regulatory Affairs and in the Danish Medicines Agency as CMC assessor of biologics. Lone has extensive experience within Regulatory CMC worldwide.
VP of Clinical Development
Austin received his medical degree from the Royal College of Physicians in Ireland in 1993. He spent the following 14 years working within the healthcare system with extensive time training and working at the internationally renowned Hammersmith Hospital and The Royal Marsden Trust, rising to a position as Resident Oncologist at The London Clinic, one of the UK’s largest private hospitals. From there he transitioned into the CRO industry, and for the past decade, he has held a position as Medical Director, Early and Experimental Oncology Clinical Development at Theradex Oncology. Austin has also undertaken specialist accreditation training as a Pharmaceutical Physician.
Executive Vice President International Operations
Marie joins LINK Medical with a background in senior management and board membership within the CRO industry for over two decades. She holds a degree in Clinical Research and has longstanding experience in clinical development and regulatory strategy within the field of oncology, advanced therapies, biologics and gene therapies. She also serves the European Commission in reviewing the progress of Horizon 2020-funded clinical trials as an external expert and monitor.
Christina joined Link Medical as a senior biostatistician in December 2020 and has been in the CRO industry since 2013. Christina has experience in running all phases from I-IV and experience in statistical programming, including knowledge in CDISC. She pursued her university studies in Lund, where her main studies were statistics, mathematics, and physics. She also acted as a teacher assistant and lead classes for a-level students at the Department of Statistics. Before joining the CRO industry, Christina worked at Skåne University Hospital with quality registries.
Group Manager, EDC
Mario joined LINK Medical in 2018 as Biometrics Project Manager and holds a Master of Medical Science (Biomedicine) from Uppsala University. He has a background in the pharmaceutical industry, mainly from manufacturing and quality control, and more than 7 years of experience in Biometrics in clinical trials. In-depth knowledge of eCRF build and data management from clinical phase I-IV.
Director International Safety Operations
Tina holds both a MD and a Ph.D. from Copenhagen University and apart from residential and medical internship positions, she has conducted both pre-clinical and clinical research within the field of cerebral blood flow autoregulation and psychoneuroendocrinology. Furthermore, she has worked as a sub-investigator in clinical phase I-IV at the Danish Dementia Research Center. In addition, Tina has more than 15 years of experience within the pharmaceutical industry, mainly with clinical trial safety and pharmacovigilance, and a period as GVP inspector at the Danish Medicines Agency, before joining LINK Medical in August 2020, as head of International Safety Operations.