Shows
PharmaLex TalksOptimizing revenue from mature products We talk with Paula King, Director, Regulatory Affairs at PharmaLex to better understand the growing trend toward regulatory outsourcing, particularly of the mature product portfolio. Hear how leading companies are sustaining revenue streams and renewing focus on innovation by optimizing the operational costs of complying with stringent regional and local regulatory requirements. 2025-07-1809 min
PharmaLex TalksWhat’s happening with eCTD 4.0: New and future developments Join Karl-Heinz Loebel, Director, Regulatory Informatics & Operations at PharmaLex, as he discusses current progress of eCTD 4.0. Ten years after the eCTD 4.0 standard became available for submissions to any ICH-participating regulatory agency, there is movement in some regions towards implementation. Karl-Heinz shares his knowledge and perspective on the journey so far and the outlook for further eCTD 4.0 adoption. 2025-07-1820 min
PharmaLex TalksChallenges and best practices for managing local pharmacovigilance activitiesIn this episode of the PharmaLex Talks Podcast, sits down with Alex Brenchat, Vice President of Local Affiliate Pharmacovigilance Services at PharmaLex, a Cencora company. Together, they explore the complexities of pharmacovigilance (PV) in a global context, focusing on the unique challenges faced by local affiliates in navigating diverse regulations post-marketing. With over 20 years of experience in the pharmaceutical industry, Alex shares valuable insights on balancing local requirements with global standards, the resource-intensive nature of PV activities, and effective strategies for outsourcing these critical functions. Listeners will gain a deeper understanding of the importance of local expertise, streamlined processes, and...2025-05-0912 min
#ChatsWithChaudhrey the PodcastS03 E07 #ChatsWithChaudhreyThePodcast #ReflectionsandForecasts 2022 23 with PharmaLex Ireland's Jane Lyons Feb 7th 2023I sat down with Jane Lyons, Country Manager, PharmaLex Ireland, and European Co-Ordinator for Quality Management and Compliance, as part of my ongoing #ReflectionsandForecasts 2022/23 interview series.We covered a wide range of topics including#Hybridworking, #Onshoring, #BREXIT, #ATMPS, #AI, #Blockchain, #ANNEX1, #outsourcing and more.I asked her....2022 𝐑𝐞𝐟𝐥𝐞𝐜𝐭𝐢𝐨𝐧𝐬 • Can you give me a quick overview of #PharmaLex? 00:55• One word to describe 2022 and why? 02:04• What were some of #PharmalexIrelands key achievements in 2022? 03:10• What has been client reactions to PharmaLex's continuing the hybrid working model 04:42• Looking back at 2022 what challenges did y...2025-04-2221 min
PharmaLex TalksEnvironmental Risk Assessment and its growing importance in the German Pharma StrategyJoin Angela-Vogt Eisele, Associate Director Scientific Affairs at PharmaLex, a Cencora company for this podcast, where she shares her expertise in Environmental Risk Assessment and its growing importance in the German Pharma Strategy2025-04-1420 min
pharmaphorum PodcastDefining, building, and implementing in the next wave of biopharma R&DIn a new pharmaphorum podcast, web editor Nicole Raleigh speaks with two PharmaLex experts about navigating complex R&D processes to unleash the next wave of biopharma breakthroughs.
PharmaLex’s Dr Christian Schneider, VP & Chief Medical Officer, Clinical Development Services, together with Dr Christelle Boileau, Director of Regulatory Development Strategy and IPD solution lead at PharmaLex, which is part of Cencora, explore the many challenges faced across the clinical trial landscape when it comes to new therapies, including ATMP development.
From preclinical to market access and regulatory considerations, Dr Boileau warns that development is not a...2025-02-1325 min
PharmaLex TalksFinding the best approach to manage sterility assuranceJoin PharmaLex's Patrick Nieuwenhuizen for this podcast, where he shares his expertise in sterility assurance and how manufacturers can demonstrate that the finished product is sterile through a holistic contamination control strategy (CCS), based on a risk assessment.2025-01-2715 min
PharmaLex TalksCommercialization ReadinessPharmaceutical companies new to the EU market must navigate complex and varying commercialization requirements. The podcast highlights key steps for commercialization readiness in Europe, focusing on the challenges non-EU companies face, including supply chain logistics and regulatory complexities. Early planning, strategic partnerships, and understanding local regulations are essential for successful product launches in diverse European markets.2024-11-0413 min
PharmaLex TalksKey Steps for Site Inspection Readiness
Louise Uí Fhatharta bio
Quality professional with over 20 years’ experience in Microbiology, Quality Control and Quality Assurance roles in the Pharmaceutical Industry including Sterile Fill Finish and Medical Device.
Involved in site and laboratory expansion projects from design through to method transfer and operational readiness. Supported site in a capacity of Quality, Sterility Assurance and Microbiology Lead oversight during projects. Through Industry experience strong analytical and problem-solving skills have been attained and highly developed strong leadership skills. Successful experience of leading FDA, HPRA and DEKRA Health Authority inspections.
2024-06-2717 min
PharmaLex TalksCSS OverviewA contamination control strategy (CCS) is integral to Annex 1 and is fundamentally about patient safety and identifying and avoiding contamination pathways. Manufacturers are expected to implement a CCS across their facilities in order to define all critical control points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamination. The CCS should be actively updated and should drive continuous improvement of manufacturing and control methods. Join our podcast where Londa Ritchey and Patrick Nieuwenhuizen, PharmaLex experts in quality management and compliance, share their insights on the purposes and pathways of a CCS.2024-05-0914 min
PharmaLex TalksExploring the interactions between validation and technology transfer
Synopsis: In this podcast, Gerardo Gomez talks about the interactions between validation and technology transfer, considering the views and expectations of the regulators. As Gerardo explains, technology transfer is really a very sophisticated and complex project management activity and therefore needs to be carefully planned to avoid discrepancies or deviations from the regulations.
Bio: Dr. Gerardo Gomez has more than 25 years of experience in the Pharmaceutical and Biotechnology industries. He has held technical and leadership roles in the areas of validations, technical transfer, operations, and regulatory compliance in major biopharmaceutical companies. As part of the PharmaLex leadership team, Ge...2024-01-2413 min
PharmaLex TalksEarly access programs: What they are and how to plan for themSynopsis: Early access programs are designed to allow patients suffering from a life-threatening unmet medical need or disease to be given promising treatments that have not yet received marketing approval. Examples of these types of programs include named patient programs, which are for a specific patient suffering from a rare, ultra-rare or life-threatening disease, and cohort programs, where patients with the same disease have been identified.
Bio: Patrick Larcier is Senior Director at PharmaLex, where he draw on his 30 years of experience in drug development and regulatory affairs at biotechnology companies, CROs and in consulting. Patrick works on S...2023-12-0515 min
PharmaLex TalksAssessing gaps and achieving compliance with Annex 1
Bio Patrick Nieuwenhuizen
Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose.
Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality, Sterility Assurance and Microbiology oversight where relevant during these projects.
In addition to site responsibilities, involved in several corporate initiatives such as Sterility Assurance Council and the roll-out of corporate standard pr...2023-11-2815 min
PharmaLex TalksNavigating the Process of Technology TransferSynopsis: Technology transfer involves two main types: scale-up and transfer to a different site. Scale-up technology transfer involves moving a technology or process from a laboratory or pilot-scale environment to a larger production scale. Transfer to a different site involves relocating a technology or process from one location or organization to another. Listen to the podcast to learn more about technology transfer and important considerations for success.
Bio: Olena Chervonenko is Associate Director Quality Management and Compliance at PharmaLex, where she draws on her expertise in quality management and regulatory compliance to support clients and her team. Olena...2023-11-1418 min
Vital Health PodcastChristian Schneider, CMO Biopharma ExcellenceChristian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK’s MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe’s Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights both the risks and opportunities of the EU’s proposed revision of the general pharmaceutical legislation. This podcas...2023-11-0849 min
PharmaLex TalksScaling Patient Safety through Innovation
Bio: Michael Braun-Boghos
Michael has been working in medicinal product safety for the last three decades. He spent 13 years at the European PV headquarters of Fujisawa, which later became Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle with the Relsys acquisition in 2009. As a senior director in the safety strategy team, he helps drive the product roadmap of the Oracle Safety One Platform including Argus, Empirica, Safety One Intake, and Oracle Analytics.
Bio: Cheryl James
Cheryl James...2023-09-2516 min
PharmaLex TalksWhy Early Phase Modeling is Key to Reimbursement and Patient AccessMarket access can be a big hurdle for companies to overcome and might require a different approach to the process of gathering evidence to support reimbursement discussions. Early phase modeling can help to inform feasibility of future adoption, the product development program, support investor communication, and sometimes even to inform decisions on whether to pursue product development or not. The podcast explores early phase modeling, what it is and why it’s becoming a key component in reimbursement and patient access.
Bio: Annabelle Fosmark is Senior Manager, Health Economics & Outcomes Research at PharmaLex and has vast experience in ma...2023-09-1211 min
PharmaLex TalksThe Unique and Complex World of Combination ProductsCombination products offer unique advantages in terms of delivering improved therapeutic outcomes or enhanced patient convenience. Typically, combination products are understood to be a drug-device or biologic-device combination. The regulatory strategy as to which center at the FDA has jurisdiction over product approval depends on their primary mode of action. Listen to the podcast to learn more about combination products and how they are regulated.
Guests’ bio:
John Lockwood is Senior Director, Head of Medical Devices/IVDs, Americas for PharmaLex, where he leverages his more than 28 years of industry experience across quality, regulatory, operations, development, validation, and pu...2023-08-3110 min
PharmaLex TalksAvoiding Pitfalls with your Product Development StrategyCompanies often fall into common traps in early-stage product development. These range from interactions with the regulators to their ability to manufacture their product. Forward planning is crucial, but all too often smaller companies lack the regulatory, business development or marketing expertise needed to support this way of thinking. The podcast explores some of the pitfalls companies can fall into and ways to avoid them.
An expert in global drug development, Alex Klein has over 15 years of experience at some of the world’s leading organizations including Abbott, Abbvie, and Hospira, as well as various biotech startups. Her dr...2023-08-0212 min
pharmaphorum PodcastCollaborative perseverance to bring change to medicine accessRecently, pharmaphorum web editor Nicole Raleigh spoke with Herbert Altmann, head of commercialisation and access solutions Europe at PharmaLex, and Casper Paardekooper, partner at Vintura. AmerisourceBergen completed the acquisition of PharmaLex (and Vintura, which was owned by PharmaLex).
2023-07-2826 min
PharmaLex TalksNavigating a complex global regulatory environment to bring medicinal products to marketThe pharmaceutical industry has been globalizing for many years as demand for medicinal products grows and as companies look to expand into the large and increasingly prosperous emerging markets. The impact of rapid globalization is that the industry is dealing with complex and ever-changing regulations and government policies that can vary across jurisdictions. The podcast explores the opportunities and challenges of globalization.
Bio: Dr. Jürgen Hönig is Senior Director, Regulatory Business Intelligence, where he participates in the design of regulatory affairs strategy, analyzes trends in the pharmaceutical and regulatory devices industries and supports the interface between re...2023-07-1813 min
PharmaLex TalksSafety Reporting Requirements for Marketing in the EUFor US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. The podcast explores the challenges faced managing not only the European pharmacovigilance legislation but also dealing with each EU Member State, which can implement these requirements in their own way at the national level.
Bios:
Monica Buchberger is senior director of pharmacovigilance at PharmaLex, drawing on her many years in industry in pharmacovigilance and regulatory roles, including quality assurance systems and serving as the...2023-07-0620 min
PharmaLex TalksThe important role of AI in TMF oversightArtificial intelligence is playing an increasingly important role in document management in the life sciences industry and in particular in improving management and oversight of the Trial Master File (TMF). The podcast explores why and how AI is a gamechanger for the TMF and what it means for pharmaceutical companies now and in the future.
Bio:
Jim Horstmann is Product Manager of Clinical Products at Phlexglobal where he draws on his extensive experience in document management solutions that comply with health authority regulations while also being easy to use and interoperable with other systems. For the past 11 y...2023-05-2412 min
PharmaLex TalksTackling performance requirements in the more prescriptive world of IVDR
Summary:
IVD manufacturers must perform two types of performance studies, clinical performance and analytical performance, in order to provide evidence that the device is safe and performs as intended.
While both have always been required, IVDR is a lot more prescriptive.
Speaker:
Keely So is Manager, Medical Devices / IVD at PharmaLex, leveraging her extensive knowledge of the regulatory requirements in Australia, Europe, New Zealand, the USA, Canada and Asia to help clients with new product licensing and launch, regulatory impact and gap assessments, CE marking of devices and IVDs, ongoing product compliance initiatives and audit...2023-04-0513 min
PharmaLex TalksGaining efficiencies with custom statistical solutions in a GxP setting
Summary:
A lot of statistical work within pharmaceutical companies is repetitive and this costs money and resources, especially if it’s done within GxP environments where there is often a need for double programming, extensive data quality control and meticulous follow-up of procedures. The podcast explores requirements and ways to develop fully automated solutions and processes to address this repetition and improve overall business efficiency.
Speaker:
Davor Josipovic is senior manager statistics and data science at PharmaLex, focusing on developing innovative solutions for questions the pharmaceutical industry faces, using applied mathematics, probabilistic modelling and machine learning.
...2023-03-1513 min
PharmaLex TalksHow the quality culture impacts GMP activityA strong quality culture in the biopharmaceutical industry is one in which all participants in the organization understand patient safety and how their roles impact patient safety risks. It is one where decisions are prioritized based on patient safety first. From a GMP perspective, that means not only abiding by the formal law but knowing the applicable current best practices, understanding the risks a company’s processes and products pose to patients and implementing effective quality risk management practices.
About the speaker:
Londa Ritchey is Quality Director with the Quality Management and Compliance group at PharmaLex.2023-02-2221 min
PharmaLex TalksManaging the medical device pre-submission process with the FDAThere are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub) program, these pathways are a way of communicating with the regulator to obtain their feedback on particular topics that are germane to both the manufacturer and the regulator.
About the speaker:
Mohammad Asad is the Regional Sales Manager – Asia Pacific at PharmaLex, where he draws on his consulting and industry experience in Australia, the US, and Singapore and on his engineering analytical background to help start-ups and larg...2023-01-1714 min
PharmaLex TalksDigitalization as a tool in the outsourcing journeyWith pharmaceutical companies increasingly turning to outsourcing partners to support maintenance of marketed products, efficiency and reliability are imperative. Digitalization, in particular automation and AI, plays an integral role in streamlining processes and enhancing that outsourcing relationship.
Timm Pauli is Vice President and head of R&D informatics at PharmaLex, where he combines his informatics and systems expertise with his experience in the pharmaceutical industry. Timm has been with PharmaLex for more than 8 years in a series of senior roles. Before joining PharmaLex, Timm worked in various technology-driven R&D roles at leading pharmaceutical and healthcare companies. Timm...2023-01-0912 min
PharmaLex TalksImproving efficiency and mitigating risk through strategic product developmentThis podcast introduces the concept of strategic product development as part of an integrated strategy to bring new drugs to the patients that need them. This holistic approach helps to save time, reduce overall development costs, and identify and mitigate risk throughout the product lifecycle. 2022-12-0512 min
The Health PulseThe Health Pulse S3E12: From radical to routine: The use of Bayesian statistics in clinical trialsMore than a decade ago, Bruno Boulanger made a big bet on applying Bayesian statistics in clinical trials. At the time, very few in the industry thought the method, which applies probabilities to statistical problems, had a place in clinical development. Boulanger saw an opportunity, founding a company that quickly grew and was acquired by CRO PharmaLex in 2018, where he now serves as global head of statistics and data science.In this episode, Boulanger explains how Bayesian statistics uses probability and prediction to solve challenges in the increasingly complex world of clinical research and clinical trial design...2022-11-1514 min
Risk RevolutionICH Q9 Revision, Is It Enough?This episode originally aired on February 15th, 2022
In this episode, Nuala Calnan and Valerie Mulholland discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further.
Resources from this episode:
ICH Q9 Quality Risk Management Revision - https://www.ivtnetwork.com/article/ich-q9-quality-risk-management-revision
Link to the new guidance - https://database.ich.org/sites/default/files/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf
Understanding...2022-11-1356 min
PharmaLex TalksBayesian and ICHQ2 and Q14
Introduction:
The ICH-Q2 and ICH-Q14 together describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products. But what is it that defines the quality of a reportable value? The podcast explores how Bayesian statistics makes it possible to take an observation made during the validation of the analytical procedure and predict the uncertainty around any future result, and in so doing bridge the gaps that exist in the guidelines.
About the speaker
Bruno Boulanger, Ph.D., is Global Head Statistics and Data Science at...2022-10-0617 min
PharmaLex TalksHow Bayesian thinking addresses complex issues with clinical studiesBrad Carlin is a statistical researcher, methodologist, consultant, and instructor. He currently serves as Senior Advisor for Data Science and Statistics at PharmaLex, an international pharmaceutical consulting firm. Prior to this, he spent 27 years on the faculty of the Division of Biostatistics at the University of Minnesota School of Public Health, serving as division head for 7 of those years. He has also held visiting positions at Carnegie Mellon University, Medical Research Council Biostatistics Unit, Cambridge University (UK), Medtronic Corporation, HealthPartners Research Foundation, the M.D Anderson Cancer Center, and AbbVie Pharmaceuticals. He has published more than 185 papers in refereed books and...2022-09-0815 min
PharmaLex TalksHow the MDR has changed the roles and responsibilities of “economic operators”Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain obligations are properly followed through to complaint management, the roles of all economic operators are affected and require careful consideration by companies with devices in the European market.
Clare Huntington is Director and Head of Medical Devices / IVD UK at PharmaLex
Clare leads the UK a...2022-08-0813 min
PharmaLex TalksThe New Opportunity in Pharmaceutical Outsourcing: Portfolio MaintenanceThe next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature products.2022-07-0615 min
Drug SolutionsThe Criticality of Training in Aseptic ProcessingJust how important is training for aseptic processing? Human error is one of the biggest pitfalls for contamination in aseptic processing, and the proper training of staff continues to be of the utmost importance. In this Drug Solutions Podcast episode, Patrick Nieuwenhuizen, director senior consultant, PharmaLex, shares how important training is for aseptic processing along with environmental controls, the differences in aseptic processing for small and large molecules, how single-use technologies impact aseptic processing, how aseptic processing can be better automated, and much more.
SPONSOR: CoreRx2022-06-0726 min
Business Matters with Karl FitzpatrickJane Lyons of Pharmalex Ireland provides an insight into regulatory compliance within the Pharma industry Hosted on Acast. See acast.com/privacy for more information.2022-06-0412 min
PharmaLex TalksSolving the Innovation Dilemma with Integrated Product DevelopmentA recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market.
To find out more, we speak with Frédéric Pailloux, Senior Director, Head of Integrated Product Development & Consulting, at PharmaLex.2022-06-0111 min
PharmaLex TalksHow software is changing the use of and types of medical devicesClassification and regulation around medical device software has become more complex, and in recent years most regulatory authorities have tightened the regulatory pathways. The podcast explores software differences and how these impact regulator classifications in various markets. It also looks at key considerations for managing the oversight of these products, in particular with regards to a quality management system.
Yervant Chijian, Director, Team Lead Medical Devices / IVD, Australia
Yervant provides expert technical consultancy for Medical Device regulatory compliance in major markets, ensuring efficient market access. He has spent the last 20+ years in the Medical Device field, including both...2022-05-1313 min
PharmaLex TalksAnnex 1 – Are you ready for implementation of the new Annex?Some major changes have been outlined in the EU Annex 1 Revision. Listen to PharmaLex expert Patrick Nieuwenhuizen on how the industry can implement the new Annex 1.2022-04-0616 min
PharmaLex TalksGetting Ready for the IVDRIVDR Brings Huge Change to Manufacturers Distributing Products in Europe
The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where approximately 80% of products were self-declared to the IVD Directive.
Listen to our expert, Terrance Thiel, in the latest PharmaLex podcast to learn more.2022-03-1114 min
#ChatsWithChaudhrey the Podcast#ChatWithChaudhrey #ReflectionsAndForecasts 2021/22 with PharmaLex Ireland's, Jane Lyons, 24th January 2022I sat down with Jane, who is Country Manager for #PharmaLexIreland to get her thoughts on 2021 and predictions for 2022.I asked her....• Give me a quick overview of #PharmaLex and her role? 00:33• What does a Country Manager do? 01:19• For one word to describe 2021 and why? 01:54• How did the pandemic impact the business in 2021? 02:49• What were some of the key business achievements for that stood out for her? 04:29• Looking back at 2021 what developments, stories and trends stood out for her? 05:36• Are there any areas Jane think the...2022-03-0517 min
PharmaLex TalksThe Why, How, When and What of EU MDR RegulationJean has extended experience in all phases of the product lifecycle, driving compliance from concept initiation through to commercialisation and post-market support. He provides Regulatory and Quality Assurance expertise to a broad range of companies from start-ups to multinationals and supports projects involving various medical technologies. He is bilingual in French and English and holds a Masters’ Degree of Engineering (MEng.). 2022-02-0415 min
PharmaLex TalksBayesian StatisticsThis episode of PharmaLex Talks features Bruno Boulanger, Senior Director, Global Head Statistics and Data Science at PharmaLex and an award-wining author on Global Statistics and Data Science (link https://www.pharmalex.com/bookauthority-announce-the-winner-of-the-best-new-bayesian-statistics-books-best-new-biostatistics-books-and-best-statistics-ebooks-of-all-time/).
Bruno´s visionary approach to statistics and his efforts to streamline predictive models and facilitate decision making in pharma are of considerable value for the industry. Clement Laloux, Specialist Statistics & Data Sciences at Pharmalex supports the discussion and shares his thoughts on the influence of prior usage, helping to predict recruitment in Clinical Trials.
This episode focuses around the smooth running of patient enrolment as...2021-11-2932 min
PharmaLex TalksChallenges & Regulatory landscape for ATMPsIndustry experts on ATMPs discuss the challenges and regulatory landscape with respect to the development of ATMPs, and what support and guidance is available from regulatory agencies.2021-11-1517 min
PharmaLex TalksPost Brexit landscape for the pharmaceutical industryMeeting the regulatory challenges of the post-Brexit pharma landscape
In the inaugural PharmaLex Talks podcast, host Elizabeth Hunt chats with Charley Maxwell, Director QMC / Senior Consultant at Pharmalex about the post-Brexit Pharma landscape.
Their wide-ranging conversation covers many key issues including; the cost of Brexit to the Pharma industry so far, what have been, and what are foreseen to be the biggest challenges to come, how UK manufacturers are coping, the Northern Ireland Protocol, and more.2021-09-0614 min