Compliance
Excellence day 2024
On October 23rd, we are once again arranging our popular Compliance Excellence Day in Kista! A warm welcome to a packed day of interesting lectures and networking.
A packed program
Listen in as our knowledge-sharing experts discuss a range of current topics. News, trends and other issues of great importance to the industry will be covered throughout the day. Also take the opportunity to meet several industry organizations that will be at Location.
During the day, there will be a variety of lectures for you to choose from. Whether you are interested in "Cybersecurity from a regulatory perspective" or "AI in Life Science - innovation and new challenges", we have something for you. Sign up below and leave your preferences on which lectures you want to listen to.
Some highlights
Inspiration, news, trends & networking. Sounds interesting, doesn't it? Here are some of the topics we will discuss during the day.
Strengthening pharma manufacturing in Sweden
![Janet Hoogstraate-2 Janet Hoogstraate, NorthX Biologics](https://c1.webien.cloud/pixel.webp)
Cybersecurity from a regulatory perspective
![Beatrice Beatrice Orback, Team Leader, Plantvision AB](https://c1.webien.cloud/pixel.webp)
Beatrice Orback explains what NIS2 requires from Life Science companies and how you can work with these cybersecurity requirements.
Sweden as a world leader in advanced therapies
![RISE-logo-1 RISE logo](https://c1.webien.cloud/pixel.webp)
ATMP 2030; Working to make 'Sweden a world leader in development and implementation of advanced therapies' - what does this mean and how is it going?
AI in Life Science - innovation & new challenges
![Gustav-Kristina Gustav Hoppe and Kristina Eneling](https://c1.webien.cloud/pixel.webp)
Gustav Hoppe & Kristina Eneling discuss both practical and regulatory challenges in this exciting field.
Falsified Medicines Directive efter 5 år
![Kristina-von-Sydow Kristina von Sydow, e-VIS](https://c1.webien.cloud/pixel.webp)
Kristina von Sydow talar om EU Kommissionens utvärdering av FMD. Har FMD haft den effekt som var tänkt och vilka lärdomar kan vi ta med oss?
data integrity and Compliance - a business priority
![Anders Christensen Anders Christensen, Consultant at Plantvision AB](https://c1.webien.cloud/pixel.webp)
Anders Christensen talks about future-proofing data and how organizations need to manage data integrity in a digital world.
agenda
Click on the dates below to find out more about the topics that will be discussed. When registering, please indicate your preferences for which lecture you would like to listen to during each time slot. (We reserve the right to make any changes to the agenda.)
08.30 - 09.20 Breakfast and mingle
09.20 - 09.30 Welcome speech
We look forward to welcoming all participants to our Compliance Excellence Day in October. The opportunity to get together and discuss what is happening in our industry, why and also what the future looks like is of great value to everyone who comes and is part of this day. Through networking and open conversations, we are convinced that we will all go home a few insights and experiences richer.
AI use in regulated Life Science environments - what are the guidelines today & tomorrow?
Discover how current and upcoming policies can support you in making the use of AI a success in life sciences and your business.
Emil Erlman
Consultant, Plantvision AB
Sweden as a world leader in advanced therapies - ATMP 2030 - a Vinnova-sponsored collaboration coordinated by RISE
Jennifer Rosendahl
Clinical evaluation & clinical data - how to do it & what are the challenges?
How to conduct a clinical evaluation & what to consider? We answer topical questions & give you an insight into how to successfully meet regulatory requirements.
Talare - to be confirmed
Plantvision AB
Falsified Medicines Directive 5 år - utvärdering av EU-regelverkets effekt
EU Kommissionens utvärdering av Falsified Medicines Directive och trender kring förfalskade läkemedel. Efter 5 år i full drift, har FMD haft den effekt som var tänkt och vilka lärdomar kan vi ta med oss ur ett kvalitetsperspektiv?
Kristina von Sydow
General Manager/CEO, e-VIS
Suppliers of computer systems (software) to regulated life sciences companies - how do you maintain quality in the development process?
How does a supplier ensure that they maintain the right quality in their lifecycle management, development, testing and release when they want to work with regulated Life Science companies? Here you will get advice and tips on what to consider.
Tony Forsberg
Group Compliance Officer and Senior Expert Quality & Compliance Consultant, Hiberion Group AB, Replior AB, Complior AB
Challenges in ATMP operations - validation and qualification of cleanrooms and aseptic practices
Interest in advanced therapies & the development of Pharma for ATMP is increasing in Life Science. What are the challenges & what to consider when establishing a GMP cleanroom facility of class A-D (ISO 5-8) for the manufacture of your sterile product?
Emina Vorkapic
Consultant, Plantvision AB
Notified body process & the road to successful CE marking
What is the CE marking process? Gain in-depth knowledge and insights from Notified Bodies to ensure your products meet all requirements.
Paneldeltagare:
BSI: Magnus Olla, Business Development Manager, Medical Devices – Nordics | Rise Medical Notified Body: Åsa Betten, VD & Sara Bergh, Certification Manager | Intertek Medical Notified Body: Charlotte Jensen, Planning Manager
Requirements & supplier evaluation at the same time - is it possible?
Do you need to create a set of requirements and perform a supplier evaluation in parallel? Get tips and tricks on what you need to consider in such a challenge and answers to the most common questions.
Lina Stange
Senior Expert Consultant, Plantvision AB
Jonatan Svedmyr
Senior Consultant, Plantvision AB
Our partners introduce themselves
More information will be available soon.
Cooperation partners
To be confirmed
From R&D to Manufacturing readiness - what is the right thing to do to succeed?
What are the most common challenges to take the process from R&D to regulated product manufacturing? We share tips & advice for businesses in the Pharma/Biotech industry.
Anna Renglin Lindh
Senior Consultant, Plantvision AB
Cyber and information security from a regulatory perspective
What are the requirements of NIS2 (the updated directive on the security of information and network systems) for life sciences companies and how can you work with these cybersecurity requirements?
Beatrice Orback
Consultant & Team Leader, Plantvision AB
Regulatory Affairs within Medtech - the importance of a regulatory strategy
How do you explain the importance & value of QA/RA in medical device companies to management so that informed decisions can be made & what should your regulatory strategy look like?
Talare - to be confirmed
Plantvision AB
The importance of life sciences in Mälardalen
Björn Arvidsson
Managing Director, STUNS Life science
AI's establishment in Life Science - from innovation to new challenges and opportunities
AI has been shown to revolutionize the development of new Pharma & provide faster and more accurate diagnoses than ever before. But are there only benefits to AI? We discuss both practical and regulatory challenges in this exciting field.
Gustav Hoppe
Senior Expert Consultant, Plantvision AB
Kristina Eneling
Senior Expert Consultant, Plantvision AB
data integrity and Compliance - a business priority
Future-proofing data - managing data integrity in a digital world.
Anders Christensen
Senior Expert Consultant, Plantvision AB
14:45 - 15:30 Keynote speaker: Strengthening pharmaceutical manufacturing in Sweden
KEYNOTE SPEAKER: Janet Hoogstraate, PhD, CEO, NorthX Biologics.
Janet Hoogstraate is a prominent leader in the biopharmaceutical sector and holds a PhD in Biopharmaceutical Sciences from Leiden University in the Netherlands. She has conducted research at the University of Utah and the University of Iowa in the USA and has worked in the pharmaceutical industry since 1995 in research and all phases of development as well as in local and global leadership positions.
15:30- 16:00 Mingle
Mingle / Networking with industry colleagues
Sign up today!
Don't miss this unique opportunity. Numbers are limited so make sure to secure your Location today. See you in October, right?
Information
Day: 23 October 2024
LocationKista Science Tower, Färögatan
Time: 8:30 - 16:00
What did participants think last year?
"Fantastic initiative!"
"Interesting lectures."
"Good balance between lecture and mingle time."
"Well organized."
"Nice atmosphere."
"Sign me up, I'll come next time too!"
"When are you doing this again?"
questions?
Want to know more about the event or have questions? Do not hesitate to contact Jonas.
Jonas Wandell | Compliance Excellence Day Coordinator | jonas.wandell@plantvision.se | +46 761 033 571