TOPRA - The Organisation for Professionals in Regulatory Affairs’ Post

The #October 2024 issue of #RegulatoryRapporteur is out now. In this edition, we focus on #innovation in #chemistry, #manufacturing and #controls (#CMC) and the ways #pharmaceutical #development and the entire #CMC lifecycle can be #accelerated and improved to elevate #regulatory #readiness and drive #innovation. Thank you to our #IssueEditor Victoria Goff and our contributors: Mariam Amer, Francisco Baptista, Javier Benito Simón, Rick Best, Slobodanka Cirin-Varadjan, Julien Douillet, Penny Field, Allison Gillespie, Anamika Goel, Eric Kelly, PharmD, Rajendra Kunda, Hao Liu, George Oliarnyk, Surabhi Parasher, Dr. Vivek Tomar, Imke Veltman, Tiejun Wang, Kirti Yadav and Srinivas Yerraguntla. Read #RegulatoryRapporteur online now 👉   https://lnkd.in/eMvNmx4D #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join

ICH Q2(R2) and ICHQ14 are #international #standardised #guidelines used to assess the #quality #attributes of #drugsubstances and #medicalproducts during the #lifecycle of an #analyticalprocedure. This article from Rajendra Kunda, Slobodanka Cirin-Varadjan, Rick Best, Hao Liu and Srinivas Yerraguntla in the #October 2024 issue of #RegulatoryRapporteur compares these #guidelines and discusses how they #complement each other. Read #RegulatoryRapporteur online now 👉   https://lnkd.in/e6a_yyTF #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This issue of #RegulatoryRapporteur focuses on #innovation in #chemistry, #manufacturing and #controls (#CMC) and looks at how #newtechnologies, #scientificadvances and #regulatory #guidance are accelerating #CMC development. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join

We hosted our #Essentials of #European #Pharmaceutical #RegulatoryAffairs #trainingcourse earlier this week, where our delegates gained an overview of #pharmaceutical #regulatoryaffairs in #Europe. Special thanks to our #expertspeakers Victor Goncharuk, Rachael O'Kane (G&L Healthcare Advisors), Andy Thornley and Giannis Tsogkas(G&L Healthcare Advisors. And of course, thanks to all our #delegates (Kathryn Arthur, Funmi Awotunde, Caroline Ayis, Sharanpreet Bedi, Abena Boakye, Karin Brinksma , Oliver Burgess, Davinia-Ann Cardona, Florence Cleminson, Giulia Crispino, Sunita Deshmukh, Jessica Di Donato, Zineb el Yaakoubi, Dan Harvey PCQI, Naze Haska, Marie Heinrichs, Li Huang, Tu Le, Kaitlyn Leafe, Javier Lopez Segura, Elisa Martinez-Aznar, Jasminder Marwaha, Alice Mazzoni, Luminita Motroi, Richard Olumakaiye, Lucy Paterson, Ela Puskaric, Kristin Robinson, Pablo Valenzuela Rivero, Marieke Van Daele, Ingrid Tresta Weindorfer and Tessa Wright) for making this such a rewarding session. This course is part of our range of #Basics training courses which are aimed at anyone wanting to take their first steps in #regulatoryaffairs or professionals from other backgrounds who require an introduction to the area covered.  See the full list of courses to find the right one for you👉 https://lnkd.in/eB6xkDHx 

New #regulations have made the #development of #paediatric #formulations mandatory. This article from Francisco Baptista, Julien Douillet and Imke Veltman in the #October 2024 issue of #RegulatoryRapporteur explores the #challenges associated with #medicines for #minors, and advocates early #consideration of #paediatric #formulations, both as a #cost-saving measure and from a #patient #palatability perspective. Read #RegulatoryRapporteur online now 👉   https://lnkd.in/eR5ctAFG #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This issue of #RegulatoryRapporteur focuses on #innovation in #chemistry, #manufacturing and #controls (#CMC) and looks at how #newtechnologies, #scientificadvances and #regulatory #guidance are accelerating #CMC development. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join 

Our dedicated programme of #trainingcourses has enabled thousands of #regulatoryaffairs #professionals to gain new #skills and #knowledge. But did you know we can also tailor flexible and cost-effective #solutions to meet your specific #training needs? We can deliver #bespoke one-off courses, manage your entire regulatory training programme and provide certified programmes using our comprehensive library of materials that has been developed by global leaders in the profession. Our training is delivered by a team of highly experienced #TOPRA members who are active consultants with a special interest in #professionaldevelopment. Find out more about how we can help you develop your team 👉 https://bit.ly/46oGKBw

#Artificialintelligence (#AI) has enhanced #safety and #quality in the development of #medicine. This article from Mariam Amer, Eric Kelly, PharmD, George Oliarnyk and Tiejun Wang in the #October 2024 issue of #RegulatoryRapporteur discusses how #AI, especially #LLM, can improve #efficiency throughout all stages of the #regulatory #lifecycle and facilitate #innovation, while also outlining its #limitations. Read #RegulatoryRapporteur online now 👉   https://lnkd.in/gt6D7CsX #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This issue of #RegulatoryRapporteur focuses on #innovation in #chemistry, #manufacturing and #controls (#CMC) and looks at how #newtechnologies, #scientificadvances and #regulatory #guidance are accelerating #CMC development. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join 

The #October edition of our monthly #LinkedIn #newsletter is available now, featuring the #latestnews and #developments from #TOPRA. This issue includes details of the latest edition of #RegulatoryRapporteur, #finalists for the #TOPRA #Awards for #RegulatoryExcellence, #highlights from the recent #TOPRASyposium in #Rotterdam, #training opportunities and more ⬇️. #regulatoryaffairs #humanmedicines #pharmaceuticals #medicaldevices #veterinarymedicines

We had a brilliant few days of knowledge-sharing and networking at the recent #TOPRA #Symposium 2024 in #Rotterdam. Watch our #highlights #video for a reminder of this fantastic event. Once again a huge thank you to all our delegates, speakers and exhibitors for making this year’s Symposium such a success. Bring on #Berlin in 2025! The #TOPRA #Symposium is #Europe's premier #conference for #healthcare #regulatoryaffairs, and this year’s event took place in #Rotterdam between 30 September and 2 October. We hosted it in partnership with the medicines evaluation board meb (#MEB)/College ter Beoordeling van Geneesmiddelen (#CBG), the #Netherlands' national authority of #medicines and #health products, with the theme of 'improving #healthoutcomes through #regulatoryexcellence'. Find out more about the Symposium programmes 👉 http://bit.ly/3rdC3bk #TOPRASYM24 #regulatoryaffairs