In April 2024 Ozack and Ingrid Brück Bøgh will be in Japan to share insights on strategic regulatory aspects of drug development towards EU and US and discuss how Japanese companies may approach this. The first meeting is with KPIA members in Japan – the Kansai Pharmaceutical Industries Association.

It was such a pleasure to discuss new #CMC methodologies, trends and possibilities and how to bring them to regulators at yesterday's meeting. Thanks a lot to Faramarz Moshfegh and Gunhild Klarskov Kristiansen for organizing this fantastic event and to all the participants for the discussions! I believe we all agree that we'll keep pushing the boundaries on what is possible and which methodologies to use to make you the expert on your compound, bringing much needed and safe drugs to patients in need. Reach out to Ozack ApS to hear more on how to engage #regulators on this journey!

What may be in the horizon for the Ozackians? And how do we continue to improve our ways of working? Working at Ebeltoft/Langhoff&Juhl and an inspiring night at Restaurant Moment in Rønde helped us step out of the daily deliverables to look at the future.

How to approach the Japanese Regulatory Environment and make sure you do not miss an opportunity in that region? Conclusion from last weeks learning at the conference with 8 Japanese experts from CoreMed and A2Healthcare are:
⚪ Connect with local experts in Japan to evaluate:
⚪ Relevant medical practice & unmet medical need in Japan
⚪ Possible regulatory pathways in global development considering
🔴 Ethnic Factor Evaluation
🔴 Japanese Phase 1 Trial
🔴 Number of Japanese Patients in Global/Pivotal Clinical Trial(s)
⚪ Reach agreement with PMDA on development plan
⚪ Submit Clinical Trial Application and enroll Japanese patients

'Bridging the Gap' seminar with the morning spent at Clarion Hotel CPH Airport, and the afternoon at Scantox Group in Ejby. The seminar was hosted by Scantox Group and Ozack ApS, with attendees from a number of invited regulatory consulting firms. A really great and informative day with lots of information sharing, new knowledge and great interaction. A big thank you to everyone who participated!

With the initiative of ACT EU (Accelerating Clinical Trials in EU) the European Medicines Agency (EMA) aims to change the decline observed in the conduct of clinical trials in EU. One of the drivers is a successful implementation of the new Clinical Trial Regulation (CTR) which has high priority at EMA. Contact us if you want to hear more about the initiatives included in the ACT EU.

The Belgian Agency shared their experiences after 1 year of the Clinical Trials Regulation (CTR) at a meeting in Brussels. Ozack joined the discussion at FAMPH this week on the benefits and problems to solve in the future.
The Agency stressed they do everything to make the CTR work for us all and invites the sponsors to approach them prior to submitting a Clinical Trial Application, in order to make the path to approval smoother. What more, they emphasized the benefits of the Simultaneous National Scientific Advice (SNSA), where you can involve your intended Reporting Member State (RMS) and concerned Member State (cMS), to establish communication and partnership early on in your development path. #clinicaltrials

Did you know we have a nonclinical GLP CRO right in the backyard of Copenhagen? Ozack had the pleasure to visit Scantox Group this week and discuss regulatory trends impacting animal testing in drug & device development. #toxicology #drugdevelopment #device.

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Another day of exciting meetings, connecting with new and acquainted faces making Nordic Life Sciences a vibrant hub. Reach out to #Ozack either by catching me personally or through the platform! #nlsdays

Steady wins the race!
Some ozackians & "featurings" joining the walking pathway as a team at DHL. Thanks for good fun Dagmara Grzadziela, Christina Balslev Rindshøj, Daniel Capion from Documizer, and Veronique Pascal!

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- Poor explanation of rationale = negative effect on application approval
- Excessive length, repetition, verbose = main document quality issue
These are some key findings from a survey of regulators opinion, shown at session on "Medical/regulatory writing in the view of the regulator" at DIA 2022 Global Meeting.
This confirms the value of well written dossiers for regulatory submissions.

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We are happy to announce our new collaboration with SDS Life Science #collaboration #lifescience

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Is your company ready for the EU Clinical Trials Regulation (CTR)? In the Biotech Salon, organized by the DANSK BIOTEK, two Ozackians Ann Christine Korsgaard and Ivana Glatzova, joined by Lene Grejs Petersen from the DKMA, shared their knowledge within the CTR and the new Clinical Trials Information System (CTIS).

Key takeaways from this meeting were to see how the transition into the new Regulation will look, what functionalities the CTIS provides, and that we can offer a helping hand if you would need it.

We love to share and discuss knowledge in this area! Thank you to all the participants for joining us.
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Ozack rings the bell in our new workspace every time we create value in what we do! A big thank you for supporting us to initiate our new Ozack HQ.

#thankyou #reception #networking #ozackians

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Ozack's working weekend last week at Fyn results in work, food, and good times. Thank you, Gl. Brydegaard, for a lovely work environment! #Ozackians

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It's a week of novelties, from yesterday's meeting on #CMC to today's inspirational presentations on Novel Approach Technologies, or NAMs. We heard about how neuronal networks can predict the effect of compounds on introducing seizures (the neurobiologist in me was amazed by this), a NAM currently being introduced to regulators. #Regulatory agencies are open to the approaches and as always, it's good to involve them early. You have various options, INTRRACT meetings with #FDA and ITF meetings with #EMA, to name just a few. Thanks to Medicon Valley Alliance for organizing this meeting- it was great to exchange ideas with familiar and new faces!

The Gazelle team got together once again for this year's celebration! We will continue sharing our regulatory expertise by providing Advice to small & medium sized biotech and pharma companies on
🔹 drug development plans
🔹 when and how to ensure alignment with Regulatory Agencies
#BørsenGazelle2023

Knowledge of possible regulatory pathways is crucial, when innovative opportunities are evaluated for investment. Ozack ApS had the pleasure recently to share insights to Novo Holdings, Venture Investments on key strategic options of the European Regulatory Environment compared to US in the context of strategy for US and EU. Thanks for the opportunity

Michael Karl Bauer and Naveed Siddiqi.
#strategy #investment

Steady Steps with Team Ozack! Ozack and friends join the walk at DHL, making every stride memorable. Thanks for the great day!

#DIA Europe 2023 ended, but it just started a variety of discussions that will continue, between a multitude of stakeholders, that we're sure of! Christina Balslev Rindshøj and Dagmara Grzadziela are on their way home to summarize the take home messages and learnings- here's 5 on the legislation and regulatory landscape from the conference. Stay tuned for more!

First impressions on Day 1 of #DIA Europe- we are excited to be hearing about #EMA's focus for the future and hopes for the #innovationinhealthcare coming out of Europe.

if you're in Basel these days, reach out to either my colleague Christina Balslev Rindshøj or myself- we're looking forward to meeting old and new acquaintances!

The clock is ringing! From today all clinical trial applications in the EU will have to go through the clinical trial information system CTIS. #Ozack already gathered experience in the transition period and today we’re sharing this together with the Danish Medicine Agency and National Ethics Committee in Denmark to discuss 1 year of CTIS with the pros and cons as well as tips for best use in the future.

A Gazelle is created thanks to amazing people working together for shared & individual success in life! This is the OZ. #BørsenGazelle2022

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Time for an Ozack re-charge at Ystad Saltsjöbad before the busy autumn hits!

Two of our Ozackians are very eager to learn about development of medical devices today at the Medicon Valley Alliance seminar ‘From Idea to success in Medical Device’. Especially, we are looking forward to hearing the presentation from Tomas Camnell on ‘The need of early engagement and regulatory considerations in the initial phase of medical device development’ - a great learning opportunity to gain knowledge we can pass on to our clients!

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Innovation through collaboration - DIA 2022 in Chicago is one of the ways to do so! Excited to bring back reflections on the future of healthcare to you.

#innovation #future #collaboration #healthcare

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Develop a passion for learning. If you do, you will never cease to grow!
Ozack attended the OCT Nordic conference at Scandic Copenhagen. Our team was happy to finally come out, socialize and get new connections.

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Collaboration, Knowledge, and Connections. Yesterday Ozack attended The Future Of Swedish & Danish Life Science, and the biggest point out was: If you can dream it you can do it! In Ozack, our mantra is to help you make your dreams come true. Thank you Medicon Valley Alliance for hosting!

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