Katie Lawlor

Pharmaceutical law and administration are key foundation knowledge requirements for all QPs. Our course provides comprehensive coverage of the medicinal product legislation in both the EU and UK. Our highly interactive training course provides aspiring QPs, and other pharmaceutical quality professionals, the EU and UK pharmaceutical legislation understanding needed to carry out their duties with skill and authority and to ensure compliance with relevant laws. https://bit.ly/4dAJiAE

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📣  IT'S FINALLY HERE! After proposed changes were announced last December, the Prescription Medicines Code of Practice Authority's 2024 ABPI Code of Practice has now been published: https://lnkd.in/euDW9tdV Watch this space for our Senior Editor's guide to the key compliance changes – coming later this week! #abpicode #pmcpa

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RESPONSIBLE PERSON FOR IMPORT TRAINING at PARADIGM SHIFT CONSULTING   The addition of regulation 45-AA in the Human Medicines Regulations (2012) outlines the new requirement for the UK WDA (H) licence holder to appoint (and have available) a Responsible Person for import. Being named as an RPi on a WDA(H) means you will have a key role in ensuring the safe control of medicines, to ensure medicines imported from the EU have been QP certified.  The RPi will be approving importation from listed countries by performing checks for appropriate evidence, to confirm that each production batch of a medicine (imported from an approved country for import under the licence) has been certified as provided for in Article 51 of the 2001 Directive, or such equivalent certification procedure as applies in the approved country for import. With the UK’s departure from the EU, the existing UK Human Medicines Regulations meant that the import of a medicine into the UK from the EU would require import testing and release by a QP, under a Manufacturer Import Licence (MIA). It was recognised that there was no capacity in the UK to add lots of MIA’s with QP’s for import activity that was previously managed by WDA(H)’s. An RP can become an RPi, but additional training is required to accommodate the extra regulations, procedures and legal supply chain requirements in order to be in compliance with UK Good Distribution Practice. For more information on this course, contact us on 0990 133 0920 or visit www.gdptraining.co.uk, or alternatively email us at [email protected]. #MHRA #GDP #SOP #QMS #import #export #logistics #medicinal #storage #responsible #warehousing #temperature #management #WDA #regulations #license #Training #qualification #validation #certification #procedures #compliance #contract

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Join us tomorrow for a LIVE Small Animal Panel Discussion discussing Dog Behaviour & Pharmacology - Which drugs to reach for, when and why? For further details and to register for this discussion, visit: https://loom.ly/b2cTKzE #veterinarypractice #veterinary #veterinaryCE #veterinarycontinuingeducation #vetce

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The UK drug market has changed in recent years with the arrival of nitazenes and other synthetic drugs. Nitazenes are synthetic opioids that are often hundreds of times stronger than heroin and at least as potent as fentanyl. If you plan on using heroin or other drugs, use this information to keep yourself and your friends as safe as possible: ⏱️Go low and slow: start with a quarter hit of a new supply and wait to see the effects 🧑‍🤝‍🧑 Don’t use alone: Make sure someone you trust is present and has a couple of naloxone kits to hand 💊 If using with others it's best if only one person uses the drug first and uses a smaller dose, waiting for the peak effects to pass 🍺 Don't mix drugs: Using more than one drug increases your risk of overdose, this includes mixing with alcohol 🧍‍♀Look after your friends: Look out for the signs of an overdose, e.g. loss of consciousness, shallow or absent breathing, ‘snoring’ or loud ‘rasping’, and/or blue or grey lips or fingertips 🤳Call for an ambulance immediately if someone overdoses and give them naloxone. 🏠 Ask for nitazene testing strips from your keyworker Find out more about keeping yourself and others safe from nitazenes: https://lnkd.in/eDUPwiWf

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In the first article of our three-part series on the FDA’s Risk Evaluation and Mitigation Strategy (REMS) drug safety programs, Sherice (Sherry) Mills, set the scene on the current approaches and highlighted some of the challenges facing manufacturers in meeting their obligations. In this second instalment, Sherry looks at current solutions for manufacturers to meet their REMS obligations. https://axian.consulting/ #REMS #riskminimisation #innovation https://lnkd.in/eUPCxzDS

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Three weeks ago, Indo Search Director Josh Craven posted about the pressure on the Heads of Regulatory Affairs and Regulatory Directors to approve non-compliant products. Does this disconnect between revenue-focused CEOs and Investors mean that compliance will suffer, ultimately harming both the company and the consumer? This poses a serious issue, as it indicates a potential disconnect between CEOs' and investors' revenue-focused mindsets and the need to maintain compliance to protect consumers and uphold industry standards. The conflict of interest between financial targets and regulatory compliance raises further questions: Reputational risks: If companies prioritise short-term profits over compliance, they risk damaging their reputation, which can have long-lasting implications for their brand and customer trust. Legal implications: Non-compliant products can have serious consequences, including legal penalties, fines, and additional costs that companies must bear. Sustainability: Achieving short-term financial goals by compromising on compliance can hinder long-term business sustainability. Consumer safety: The ultimate casualty in this situation is consumer safety. Non-compliant products can lead to severe health and safety consequences. CEOs and investors must recognise the long-term value of compliance. Balancing financial goals with a robust compliance framework can promote sustainable growth and avoid potential pitfalls, benefiting both the company and the consumer. See the full post here 👇 https://bit.ly/3yesAYe

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*Sneak Preview JMDR May 2024 issue* ✨US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR)✨ On 2 February 2024, the Food and Drug Administration (FDA) published a final rule to implement the most significant revisions in the FDA’s quality system requirements for medical devices in decades. Specifically, the final rule – known as the Quality Management System Regulation (QMSR) – will largely replace the FDA’s existing Quality System Regulation (QSR) with ISO 13485. The final rule also makes conforming edits to clarify the device Quality Management System requirements for combination products. This article by Pamela Forrest and Amy Leiser summarises the content of the QMSR, key differences between the QSR and QMSR, and steps that manufacturers should take to prepare for implementation of the QMSR. #regulatoryaffairs #medicaldevices #iso13485 #usfda #qsr #qmsr #dispositivosmedicos #dispositifsmedicaux #medizinprodukte #medtech #dispositivimedici #qualitymanagementsystem Subscribe now so you don't miss the full story: 👉 https://lnkd.in/dUiFxgap

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US FDA News!! (Accreditation Scheme for Conformity Assessment (ASCA)) The FDA has today published 3 draft guidance's regarding the 'Accreditation Scheme for Conformity Assessment (ASCA)' The following guidance's have been released: • The Accreditation Scheme for Conformity Assessment (ASCA) Program: https://lnkd.in/enJVaAhC • Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: https://lnkd.in/ecxNaSrq • Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: https://lnkd.in/exwGjFif These guidance's include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase. The draft guidance's are available for comments until 22 November 2024. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #ivd #medtech #euivdr #eumdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #udi

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🚨 Is it time to rethink your divisional patent strategy?    Teva Pharmaceuticals has recently been fined €462.5m due to alleged misuse of the EPO’s divisional patent system, raising a critical question for patent holders: are you managing divisional filings in a way that could be seen as anti-competitive?   This recent ruling by the European Commission underscores the need for companies to carefully assess their approach to divisional patents, balancing innovation protection with regulatory compliance. Find out more about the implications for your IP strategy in Arnie Clarke's latest analysis: https://lnkd.in/eMQj3_uZ

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What is needed to support a QP declaration? Answer: The QP completing the QP Declaration must have access to audit reports of Drug Substance and Drug Product manufacturing and testing sites conducted within the last 3 years, demonstrating site compliance with GMP. A copy of the final IMPD to be used to for the CTA submission, a copy of the auditors CV and quality agreements in place with the sites are also required. Following the review, the QP will confirm whether the documentation provided allows completion of the QP Declaration.

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It’s never too early to start thinking about your New Years Resolutions, so why not have yours been the organisation of appointing your #UKRP ? If you’re a non-UK manufacturer, the regulations state you must have a UKRP (United Kingdom Responsible Person) appointed to ensure your products and processes adhere to the UK regulations You can read more about the importance of a UKRP here, and just how IVDeology can start off your 2025 year strong! https://lnkd.in/ez9w5ht2 #responsibleperson #medicaldevice #invitrodiagnostics #IVD #IVDR #regulatoryaffairs #QARA

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✅ Dedicated project management throughout your journey ✅ QP batch certification (including release for sale) ✅ Tailored regulatory package, based on your requirements and timescales. Learn more in our new information sheet: https://lnkd.in/e8arT3C2 #regulatorycompliance #pharma #pharmaceutical #centralpharma #regulatorysubmissions #regulatoryapproval #importation #pharmalogistics #qp #gmp #gdp

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External contamination remains a prominent concern in hair testing. Dr Lolita Tsanaclis, Cansford Laboratories Ltd. Co-Founder and Chief Scientific Officer, addresses this issue in her latest chapter, offering practical recommendations to enhance testing interpretation and reliability. Published by the Royal Society of Chemistry in ‘Perspectives and Challenges of Hair Analysis’, the chapter delivers invaluable insights for students, legal professionals and stakeholders engaged in drug and alcohol testing. You can read the full article here: https://lnkd.in/daaE8QuE #HairTesting #HairAnalysis #Toxicology #LegalInsights #CansfordLabs

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2024 IRCA GxP, ISMS and PQMS Lead Auditor Reassessment Complete! I’m delighted to share that I’ve once again successfully completed my IRCA reassessment; this year, I was selected for GxP Lead Auditor evaluation. I can't believe I have been an ongoing member of CQI and IRCA since 2016. Where does the time go? The funny thing is, even after all this time, I still get apprehensive ahead of each re-assessment. That's because the reassessment process goes beyond theoretical knowledge and evaluates how I’ve applied my auditing skills over time. It involves a thorough review of examples of audits I’ve conducted, how I’ve addressed challenges, and how I’ve adapted to evolving expectations and regulations. This reflective process reinforces the importance of staying current. This reassessment was a valuable opportunity to ensure and prove my skills remain sharp and relevant. It’s a reminder of how critical it is to align audit practices with the ever-changing regulatory landscape to meet compliance requirements and add real value. So a massive thank you, IRCA, for creating a robust framework that supports professional growth and excellence. To my fellow auditors: How do you ensure your practices evolve with the industry? #ProfessionalGrowth #IRCA #AuditingExcellence #ContinuousImprovement

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The updated Clinical Trials regulations also include the ability to use simplified means of seeking and recording consent in 'lower risk' trials. These are trials involving medicines that have already been approved and therefore pose minimal risk to participants. Kerry Woolfall, Professor in Health Research Methodology at the University of Liverpool gave her reaction to the updated regulations being laid before Parliament today. Read more about the UK's updated Clinical Trials regulations on our website. https://lnkd.in/ew9ACSMK #ClinicalTrials #Research #NHS #Consent

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📢 𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐔𝐩𝐝𝐚𝐭𝐞 𝐨𝐧 𝐔𝐊 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐌𝐇𝐑𝐀! The MHRA has announced significant changes to pharmacovigilance for medicines authorized in the UK, taking effect from 1 𝐉𝐚𝐧𝐮𝐚𝐫𝐲 2025.  These changes, in line with the Windsor Framework Agreement, impact how pharmacovigilance will be managed, with specific variations for 𝐂𝐚𝐭𝐞𝐠𝐨𝐫𝐲 1 𝐚𝐧𝐝 𝐂𝐚𝐭𝐞𝐠𝐨𝐫𝐲 2 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬. 🔔 𝐌𝐇𝐑𝐀 𝐑𝐞𝐩𝐨𝐫𝐭𝐢𝐧𝐠: - From 1 January 2025, all Marketing Authorisation Holders (MAHs) must submit UK ICSRs and serious non-UK ICSRs that meet MHRA reporting requirements within:  - 15 days for serious reports  - 90 days for non-serious reports - For cases related to Northern Ireland (NI), the country code XI will continue to be used. 🔔 𝐄𝐌𝐀 𝐑𝐞𝐩𝐨𝐫𝐭𝐢𝐧𝐠: - Category 1 products (EU or EEA license): Serious UK and other country reports must be submitted to the EMA within 15 days, while non-serious ICSRs from NI should follow EMA requirements. - Category 2 products: MAHs must submit all serious UK and other country reports to the EMA, including non-serious ICSRs from NI or EEA states, within the prescribed timelines. 🗂️ 𝐏𝐒𝐔𝐑 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧: - Category 1 products: Follow UK-specific submission rules via the MHRA PSUR portal. - Category 2 products: Use the EU PSUR Repository, aligning with the EU's single assessment process. For full details, visit the official MHRA guidelines here: [MHRA Pharmacovigilance Update](https://lnkd.in/eKH3rHqe) 📄 💡 Need expert assistance with your pharmacovigilance processes ? Universal Medica provides comprehensive pharmacovigilance services, including reporting, case management, and regulatory support. Learn more about how we can help at 👉 https://lnkd.in/dtUabmV 🌐

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