Arriello

We're #hiring a new Associate Director of Global Drug Safety/ Safety Physician in Ireland. Apply today or share this post with your network.

The European Medicines Agency (EMA) has a rigorous regulatory framework. For Small and Medium-sized Enterprises (SMEs), the complexity and ever-evolving nature of EMA guidelines can present significant challenges. This new case study https://lnkd.in/emZc6dWT highlights how our expert team successfully guided a client through the EMA submission process, ensuring a smooth and efficient approval. Key Challenges: * Complex Regulatory Landscape: The EMA's stringent requirements and tight timelines can be daunting, especially for those without prior experience. * Product-Specific Challenges: The client's product faced unique complexities that required careful consideration during the pre-submission and review phases. * Limited Resources: As an SME, the client needed to balance their internal capabilities with external expertise to manage the challenges effectively. We can help. We have a knowledgeable and experienced team who can help plot a path through this process. Contact [email protected] #pharmaceuticals #pharma #drugdevelopment #biotech

The team had a fantastic day at PDA Ireland's latest conference, Biopharmaceutical Mfg Conference: Embracing Technology and Innovation. As sponsors we wish to thank all attendees and the orgnaizers for an insightful agenda and a great networking opportunity in Dublin at the Carlton Hotel Dublin Airport. * Kate Coleman VP Regulatory, Quality & Compliance (Principal Consultant) * Vic Cowper (CCO) and * Neha Prabhudesai (Commercial Development Specialist) All from our Dublin head office travel home and prepare for yet more conferences and events this quarter! See you at the next one. A reminder for anyone that we didn't get to speak to, that you can DM the team or email contact [email protected]. #PDA #Pharmaceuticals #biotech #pharma

Fresh from the CustomerGauge client experience awards! While we didn’t take home the top prize in our category, we’re incredibly honored to have been a finalist alongside such amazing companies. A big congratulations to SuperOffice (winners in our category) and Coca-Cola Bottlers Japan Inc. who won the CPG equivalent. And of course, a round of applause to all the other nominees for their outstanding work in customer experience. #CX #awards #pharma #pharmaceutical #biotech

Today is the International Pharmaceutical Federation (FIP) World Pharmacists Day – with the theme of “Pharmacists: Meeting global health needs” We recognize the incredible work of pharmacists around the globe. From dispensing medications to providing invaluable health advice, pharmacists play a vital role in keeping us healthy. Let's appreciate and celebrate their dedication and expertise. Pharmacists serve as integral members of healthcare systems, playing a vital role in meeting health needs. First and foremost, they ensure access to essential medicines and their optimal use, but they also use their expertise to contribute significantly to patient care and public health. In many places, pharmacists are the first point of contact for health advice and primary health care, especially in resource-limited settings. They help prevent diseases (e.g, through administering vaccinations); they conduct health screening, educate patients and help to improve health literacy; they support public health campaigns, participate in research and development of new medicines, aid pharmacovigilance and make sure that antibiotics are used only when needed; they are implementing greener ways of working and addressing the impact of climate change on health; and they advocate for policy changes that promote better health outcomes. And, as demonstrated during the COVID-19 pandemic, pharmacists are at the forefront of addressing global health crises. Thanks to all involved across the sector. #WPD2024 #Pharmacists #Pharma #Pharmaceuticals

An update on the Windsor Framework deadlines this week from our #pharmacovigilance #drugsafety team. One of these deadlines looms on the 30th September! Read more below. Mutual recognition- PLNI & PLGB product licenses cannot coexist for the same product after 01 Jan 2025, so the following actions must be performed by the dates below * The MAH must request withdrawal of NI from the MRP and cancellation of the PLNI before 30 Sept 2024 ( with effect from 31 December 2024) * If the cancellation of the PLNI is not requested, this will be cancelled by the MHRA by 31 December 2024. * From 01 Jan 2025, ICSR reporting requirements will be based upon whether the product is category 1 or category 2 . These categorizations will also affect items such as PSUR submission requirements and  PSMF metrics.   Product Labelling – From 01 Jan 2025, ‘UK Only’ must be on all new packs placed on the market, ( this statement can applied using stickers until 30 Jun 2025 as an interim measure) . EU FMD packaging, labelling and barcode requirements must not appear on medicines being supplied to the UK from 01 Jan 2025. MAHs can apply now for the labelling updates and implement the updated packs ahead of the 01-Jan-2025. The current self-certification labelling notification approach will be valid for use as no specific W.F application is required or available for use. Companies must notify the MHRA of any new artwork changes and have until 31 Dec 2024 to do so. This notification may be done by any of the 3 current allowable routes e.g. as part of another regulatory procedure ( excluding type 1A variations), Via a labelling self-certification notification made under Regulation 267 or vial a labelling notification made under Regulation 267 where an eCTD sequence is not initially provided but will be provided as part of a subsequent Regulatory submissions by 31 Dec 2025, however careful considerations of the timelines must be made to ensure the approval prior to the due date. For more suport with this then please contact the team via [email protected]. #pharma #pharmaceuticals

Only a few days to go! Arriello are sponsoring the PDA Ireland's latest Biopharmaceutical Manufacturing Conference: Embracing Technology and Innovation in Dublin on the 26th September. Find out more here: https://lnkd.in/exMuhyXv You’ll find Kate Coleman and Vic Cowper at our stand and if you have any questions then you can message [email protected]. With thanks to PDA Ireland and the great work they do. #PDA #Pharma #Biotech #pharmaceuticals

We're #hiring a new Associate Director of Global Drug Safety/ Safety Physician in United Kingdom. Apply today or share this post with your network.

We're #hiring a new Associate Director of Global Drug Safety/ Safety Physician in Czechia. Apply today or share this post with your network.

We’re busy preparing for World Drug Safety Congress Americas, in Boston, 29-30th October. Sam Tomlinson and Katrina Goddard, Pharm.D. our VP and Director of Global Drug Safety will be speaking on the topic of “The Unspoken Key to Your PV System,” this will focus on how, although technology now enables us, the human element plays a vital role in enhancing modern PV systems. Read more here: https://lnkd.in/ev8bxwpj . Together, Sam and Katrina will highlight the balance between technology and human expertise, showing how both elements must work in harmony to ensure that PV systems are resilient, adaptable, and compliant with the latest industry standards.  Our team will be on-site, and as gold sponsors you'll find us on stand No.319. If you're there, please say hi to Sam Tomlinson, Katrina Goddard, Pharm.D. , Alan White, and Vic Cowper. If you'd like to meet, then please reach out via DM or contact [email protected]. #pharmacovigilance #pharma #pharmaceuticals #drugsafety