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True Quality Roadshow 2024

Talk early to regulators and adjust your #regulatory strategy including risk assessment!
This is key in getting your device to market aligned by all #medical device presenters and participants at the True Quality Roadshow 2024.
This is equally important in the US and EU, with the MDR coming into effect. Dagmara Grzadziela met a lot of familiar and new faces and brought home important insights and inspirations on what is needed for
✔ clinical evaluations
✔clinical trials
✔approvals of medical devices.


Sharing knowledge at the School of Health Innovation

A room vibrating with curiosity and ideas- that's what Christina Hemmingsen and Dagmara Grzadziela met at the School of Health Innovation in Copenhagen. We had the pleasure to present the upsides of developing your #regulatory strategy early in #pharmaceutical product development. Thanks to Lilian Rasmussen and team for the invite and looking forward to continuing all the interesting discussions and options to mitigate regulatory risks!


The Japanese connection continues

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.

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Sharing knowledge at the CMC meeting: Insights and Case Studies for Successful Submissions

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!


2023 Offsite Ozack Meeting 

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.


Japan in your regulatory strategy

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

'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!


ACT EU by the EMA on DIA EU 2023

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.


1 year of CTIS in Belgium

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


Field trip to Scantox

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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NSL days 2022

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


DHL run 2022

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

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DIA 2022 in Chigago

- 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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Partnering up with SDS Life Science

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

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Ozack shares knowledge on CTIS

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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Reception at Ozack

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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Working trip at Gammel Brydegaard

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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Global drug development Webinar in Japan

Several hundred participants signed up for this meeting! The number shows a significant unmet regulatory need for understanding the non-Japanese regulatory environment.
Ozack ApS presented at this webinar in Japan last week, arranged by A2 Healthcare Corporation at their office in Tokyo. The purpose was to provide insights to Japanese companies on the many opportunities for engaging regulators in EU and US on the clinical development plan.
Another seed is planted for more early global drug development - hopefully!
#Japan #Regulatory #globaldrugdevelopment


Connecting the Regulatory options in EU and US with Japan

The world is getting "smaller" and yet there are still many different ways of achieving regulatory success with pharmaceuticals in EU compared to US and Japan. On April 15th at Kansai Pharmaceutical Industry Association (KPIA) in Osaka, it was a pleasure - together with Ingrid Brück Bøgh - to share strategic regulatory and nonclinical expertise and insights on the EU/US environment with the aim of facilitating early global drug development for Japanese companies. Thanks to Masami Tamura and KPIA for enabling this meeting.


Novel Approach Technologies meeting

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!

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Gazelle 2023

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


Key Strategic Options for Investment in the US and EU Regulatory Environments

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

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DHL run 2023

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


Last day of DIA EU 2023!

#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!


Day 1 of DIA Europe 2023

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!


1 year of CTIS in Denmark

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.


Gazelle celebration

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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Ozack trip to Ystad

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


Up the beat 

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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Ozack joins the DIA Global 2022

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


Pressrelease of new partnership


Ozack attending the OCT Nordic conference at Scandic Copenhagen

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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Ozack attending the Future of Swedish and Danish Life Science

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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