• Menu
  • Skip to right header navigation
  • Skip to main content

Before Header

Link Medical Research

CRO – Contract Research Organization

  • Home
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Experts
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
    • Other Services
  • Therapeutic areas
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Customer Testimonials
    • Our Memberships
  • News & Events
    • News
    • Events
    • Publications
    • Videos
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • LINK Team Testimonials
  • Search
  • Home
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Experts
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
    • Other Services
  • Therapeutic areas
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Customer Testimonials
    • Our Memberships
  • News & Events
    • News
    • Events
    • Publications
    • Videos
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • LINK Team Testimonials
  • Search

Top Content

Home / MVA Face to Face Morning Meeting: Surviving Early Biotech Pitfalls

Top Content 2

MVA Face to Face Morning Meeting: Surviving Early Biotech Pitfalls

Overcoming challenges when moving from non-clinical to clinical

Join our breakfast meeting together with Medicon Village Alliance (MVA) in Copenhagen and meet our experts!

When: May 24

Time: 9 to 11:15

Place: Medicon Valley Alliance,

Arne Jacobsens Allé 15, 2300
Copenhagen S, Denmark – Meeting room: Auditorium

Going from non-clinical to clinical is no easy step. That’s why we’ve gathered 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. From factors to consider when selecting a manufacturer, Pipeline strategies, to the importance of aligning your data management team and safety in early clinical studies. This presentation will be packed with insightful information for biotech, Pharma, and MedTech companies.

 

Agenda:

9:00 Networking, registration, and light breakfast

9:30 Welcome
David Munis Zepernick, Head of Member Engagement and Communication, Medicon Valley Alliance

9:35-10:35

  • Factors to consider when selecting a manufacturer: The value of a GMP audit by Hilde Ringstad, Director of Quality Assurance and Compliance
  • Non-clinical development and the importance of a Target Product Profile (TPP) by Jenny Lund, Regulatory Manger
  • The critical path for regulatory CMC – Biologics by Lone Dyrby, Regulatory Director
  • Clinical development: don’t lose sight of the target by Rikard Reneland, Medical Expert
  • Biostatisticians early in the design by Ingmari Johanson, Sr. Biostatistician
  • The importance of proper data handling by Lise Egholt, Biometrics Project Manager
  • Clinical Trial Safety by Anne Krammer, Director, Safety Operations

10:35 – Q&A

10:45 – Networking

11:15
– End

 

About the speakers

Hilde Ringstad,

Director Quality Assurance and Compliance
Hilde.Ringstad[@]linkmedical.eu

Hilde 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 the health authorities, last as head of inspection at the Norwegian Medicines Agency. She joined LINK Medical in 2018 and holds an MSc in pharmacy.

Jenny Lund,

Regulatory Manager
Jenny.Lund[@]linkmedical.eu

Jenny holds a Ph.D. and M.Sc. Pharm. from the University of Oslo, focusing on research in basal pharmacology, mainly within diseases related to metabolic disturbances, in particular insulin resistance and diabetes mellitus type 2. Furthermore, she has participated in preclinical research and medical writing for pharmaceutical companies. She has also been an external evaluator within pharmacokinetics for the EMA. She joined LINK Medical in 2021 as a Regulatory Manager, specializing in the early phase of drug development, including advising on preclinical study programs, conducting target product profiles and medical writing.

Lone Dyrby,

Regulatory Director – Denmark 
Lone.Dyrby[@]linkmedical.eu

With over 20 years’ experience within Regulatory CMC, Lone has been working extensively within biologics. She has an MSc in pharmacy and a diploma in leadership (bachelor level). Lone has been part of the LINK Medical team in Denmark since October 2020. Prior to that, she had various positions in the pharmaceutical industry as a Regulatory CMC specialist and Head of Regulatory Affairs and in the Danish Medicines Agency as a CMC assessor of biologics. Lone has extensive experience within Regulatory CMC worldwide.

Rikard Reneland,

Medical Expert
Rikard.Reneland[@]linkmedical.eu

Rikard has 20 years of biopharmaceutical experience focused on clinical development and clinical operations, with experience from small biotech to big pharma companies.  After graduating as an MD from the University of Uppsala, Rikard completed his Ph.D. in preventive cardiology.  In parallel to his research, he was working as an investigator in several clinical trials. Following his Ph.D., he received his license to practice. Shortly thereafter, he started his industry career in a pioneering small biotech company developing pharmacogenetic tests to predict response to drugs. After 6 years as Medical Advisor in early biotech and small pharma, Rikard started working as Medical Advisor at the Nordic-Baltic Clinical Study Unit at Sanofi, providing first-line medical support in studies of all phases and across disease areas. He also held positions as Country Medical Lead Immunology at Roche and Global Safety Physician at Sobi before joining Link Medical in 2022.

Ingmari Johanson,

Sr. Biostatistician
Ingmari.Johanson[@]linkmedical.eu

Ingmarie Johanson joined LINK Medical on Sept. 2020 as a Senior Biostatistician. She has a master’s degree in Medical Sciences from the University of Lund, Sweden, and has combined her education with two years of studies in statistics and worked as a medical biostatistician since 2000. She started first as statisticican at an Oncology center in Gothenburg and has worked at several CROs in Sweden and Denmark. She has also taught at the universityin Gothenburg and Lund and has been a coordinator in a large epidemiological project.

Lise Egholt,

Biometrics Project Manager
Lise.Egholt[@]linkmedical.eu

Lise joined LINK Medical in 2019 as Biometrics Project Manager and holds a Master of Human Nutrition from the University of Copenhagen. She has a background in clinical research and data management. With hands-on experience in project management, data collection, and statistical analyses, Lise has in-depth knowledge of the requirements to obtain high-quality data.

 

 

Previous Post: «CRO – Contract Research Organization HR Business Partner
Next Post: Closing the gap between developers and users results in a unique eTMF solution »

Site Footer

Don't miss out on the latest updates

Be the first to hear our breaking news at LINK Medical

  • Home
  • Solutions
  • Therapeutic areas
  • About Us
  • News & Events
  • Contact
  • Careers
  • Search

© 2023 LINK Medical Research
Privacy Policy

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent. Read More
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_gat_gtag_UA_142237341_11 minuteSet by Google to distinguish users.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
nQ_cookieId1 yearAlbacross sets this cookie to help identify companies for better lead generation and more effective ad targeting.
nQ_userVisitId30 minutesNo description available.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
CookieDurationDescription
VISITOR_INFO1_LIVE5 months 27 daysA cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface.
YSCsessionYSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages.
yt-remote-connected-devicesneverYouTube sets this cookie to store the video preferences of the user using embedded YouTube video.
yt-remote-device-idneverYouTube sets this cookie to store the video preferences of the user using embedded YouTube video.
SAVE & ACCEPT
Powered by CookieYes Logo