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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!

Click to see the post on LinkedIn

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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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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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