LORENZ Converge - The first on-site conference after a two-year break
Posted on November 23, 2022
After a two-year hiatus from holding on-site conferences due to Covid-19, we were finally able to hold the first LORENZ Converge, a successor event to the renowned userBridge and LORENZLink conferences. It was a pleasure to see old acquaintances as well as many new faces! In the picturesque city of Brussels, participants came together to learn about the latest developments in the regulatory affairs sector, to socialize and connect with peers from around the globe, and meet members of the LORENZ team to enhance their product knowledge. If you weren’t able to join us, we’ve put together this short summary of the highlights:
The event kicked off with a keynote speech presented by Raoul-A. Lorenz (LORENZ Life Sciences Group), followed by Angelina Gindeberg (Lundbeck) who shared her experiences with the implementation of a RIMS and a publishing tool, along with the challenges and considerations of moving from several vendors and platforms to a one vendor / one-platform approach. After a short break, Karl-Heinz Loebel (PharmaLex) outlined the circumstances in which baseline submissions are necessary, what to consider when compiling them for different purposes, and how to put them together efficiently. Kent Briggs (VECTOR Life Sciences) discussed the topic of eCTD for the ECOWAS region and gave an update on a planned updated application structure that has been defined for eCTD and eSubmissions. Following this presentation, Dr. Andreas Franken (BAH) addressed the transition from paper to electronic submissions. The first day concluded with a panel of experts covering Dynamic Submission Management. Dr. Andreas Franken (BAH) moderated the session in which Lorelle Leonienco (LORENZ Life Sciences Group), Charles Mathis (LORENZ Life Sciences Group), Dr. Bernd Misselwitz (Bayer), David Ross (AstraZeneca), and Shannon Laforce (Health Canada) discussed industry trends and their experiences of the most current changes happening in the Regulatory Affairs industry.
After a full day of fascinating sessions, participants were then able to socialize in a relaxed atmosphere while a jazz band performed in the Vaudeville Theatre. On the way to the theatre and on the way back, everyone had a chance to join the walking group and discover a bit of Brussels while chatting with peers.
The second day was kicked off by Remco Munnik (IPERION – a Deloitte business) who outlined the history, current state, and the future of the state of the EU Regulatory Framework. Hans Van Bruggen shed some light on how IDMP can be viewed as an enabler for many goals. He also highlighted the importance of data, which can be the biggest asset for a pharmaceutical company when supporting the quality, efficacy or the safety of drug and also the registration status. Dr. Peter Bachmann (BfArM) spoke about the international collaboration between agencies and regulatory initiatives. The final sessions of LORENZ Converge concluded with an overview of eCTD 4.0, with Dr. Bernd Misselwitz (Bayer) giving an introduction and update on the implementation status from the ICH M8 perspective. Akira Yamaguchi (LORENZ Life Sciences Group) outlined the conceptual aspects of eCTD 4.0 and showed the vendor perspective on this topic. Following this session, the event concluded with closing remarks by Raoul-A. Lorenz (LORENZ Life Sciences Group).
After the conference ended, participants could also join userGroup meetings on either docuBridge or drugTrack. These two forums offered the chance to meet other users in person, exchange product-related tips and tricks, and discuss agency guidelines. The two groups normally only meet online on a regular basis. If you are interested in joining them, click here for more information on the docuBridge userGroup or here for more information on the drugTrack userGroup.
In addition to the main presentations, LORENZ Converge followed tradition by offering a wide range of table tutorials, leaving participants spoilt for choice! The range of topics included product-related sessions such as LORENZ’s Document Management System and the well-known ‘What’s new in LORENZ docuBridge?’ session, as well as regulatory topics such as the benefits and limitations of IDMP shown in a use case and a table tutorial on the Clinical Trial Regulation 536/2014, which has been effective since 2022. Participants could also learn about how automating the identification of issues in Word and PDF content earlier in the preparation process can help streamline submission processes and reduce the risks of non-compliance.
We would like to thank everyone who joined this year’s LORENZ Converge and give a big shout-out to all of the presenters who volunteered to share their expertise. We can’t wait to see all of you again at our next LORENZ Converge which will be held in Austin, Texas. For more information, please click here.
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