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Risk management in early phase clinical trials – Practical implications

We are honored to be part of the Norwegian Embassy hosted event on March 5th. JOIN US at the ‘Risk Management in Early Clinical trials’ half-day seminar to meet Ambassador Christian Syse, our CEO Ola Gudmundsen, and the LINK Medical team.

Don’t let regulatory requirements stall your company’s innovatio­­­­­n, instead embrace the changing regulatory landscape to further develop your clinical plans, especially in the early strategic plans for prime clinical candidates.

Join us to hear how these changes are supporting innovation and helping companies such as yours to avoid pitfalls and negative results due to poorly planned studies. Getting clinical products to market is not without challenges and overcoming obstacles in early clinical development requires scientific, regulatory, clinical, and statistical strategies at every stage.  

At this meeting, you will learn from our team of experts and clinicians who will simplify what you need to know to get your drug to proof of concept as quickly and efficiently as possible. You will learn about concepts of early-stage development, the regulatory framework including key changes and, how to identify and mitigate risks in early clinical trials. 


 Agenda

13:30 – Registration

14:00 – Start and Welcome by Ambassador Christian Syse

14:05 – Welcome by Ola Gudmundsen

14:10 – Gunnar Danielson – Regulatory landscape overview and practical implications for conducting early clinical development

14:50 – Austin Smith – Drug Dev. Strategy & Changing Landscape for Biotech

15:30 – Break Coffee and refreshments

15:45 – Jeffery Yachnin: Investigator – Feedback from collective studies on what makes a study good and how to get the most out of patients

16:15 – Q/A

16:35 – Dinner

17:30  – ends


About our Speakers

 

Gunnar Danielsson, former GCP inspector has traveled around the world performing GCP inspections for the Swedish Medical Product Agency for over 10 years. He has 40 years’ experience in Clinical Research and has a wealth of experience from the Pharmaceutical industry in terms of quality management, electronic systems, data management, and clinical design and conduct. Gunnar today is a key advisory resource and helps to design studies in the most effective way, meeting regulatory requirements.

Austin Smith 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. Austin will be based at LINK Medical’s new UK office, situated in the heart of London.

Jeffrey Yachnin MD, PhD Originally from Montreal, Canada Jeffrey is a medical oncologist who took an early interest in clinical research and has been working with clinical trials since 1995. He has worked as head of the cancer trials unit at the University Hospital in Uppsala from 2006 until 2011. Since then, he has been head of the Center for Clinical Cancer Studies at Karolinska University Hospital. Mr. Yachnin works primarily with early clinical trials both in academic and industry-sponsored studies.


More Information

This is a free event hosted by the Royal Norwegian Embassy in collaboration with LINK Medical. Students and non-industry people will be put on a waiting until and will get confirmation 2 weeks before the event. We have a limited number of seats and only registered people can attend this event.

A valid ID is required when entering the Embassy.

If you have any questions regarding registration or anything else, please don’t hesitate to contact me.

Sincerely,

Claudia Wennberg

Marketing and Branding Manager at LINK Medical

+46 708 244 398

claudia.wennberg[@]linkmedical.eu

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