BioPharmaChem Ireland

This week the BioPharmaChem Ireland Quality and Regulatory Affairs Working Group convened at Helsinn Birex Pharmaceuticals Ltd, Dublin. We are grateful to Amy Young, Ailbhe Henderson, Isabelle Durcan, Marco Onofri, Florin Muraru, Frank Fitzpatrick and the wider Helsinn Birex team for their hospitality, the wonderful plant tour and for facilitating insightful and informative discussions on a variety of topics including: ☑ Process for updating artworks when not the MA Holder ☑ Parallel imports ☑ Experience with MHRA ☑ Roll out of variations worldwide   Thank you Tara Cox from Takeda UK and Ireland and Paul Scannell from West Pharmaceutical Services for their overview on the new #Combination Products Forum. As well as the comprehensive presentation on the #regulatory landscape post Brexit for combined #medical device and #pharma products. To get involved in this joint initiative between BioPharmaChem Ireland and Irish Medtech contact Karina Cassidy or Emer Sherry.   Thank you to all the members that attended for their contributions and insights. For further information on getting involved with BPCI working groups visit https://lnkd.in/etwhZqAw Sinead Keogh Siobhán Dean Michael Kilkelly Audrey Devlin Lisa Goodman Eimear Curran

The availability of a highly skilled workforce and a supportive skills ecosystem, combined with factors such as a competitive business environment, has been pivotal in Ireland’s ability to leverage the opportunities presented by the global growth of the BioPharma sector. Sinead Keogh, Director of BioPharmaChem Ireland commented: “Today in #Budget2025, we welcome the scale of investment in human capital through the unlocking of the NTF, a key ask in our Budget2025 submission. Investment in digital skills, green skills, management skills, and transversal employability skills will be critical for building the resilience of the BioPharmaChem sector. "This sector also traditionally recruits PhD graduates, allowing Ireland to move up the value chain towards earlier stage development and clinical manufacturing. Investment in Higher Education Institutes and life science research centres to ensure a robust talent pipeline of skilled graduates at both degree and doctoral levels is vital for sustained success.” 21,000 jobs are forecast by the Expert Group on Future Skills Needs for BioPharma over the next three years, on top of the 50,000 people already directly employed in the sector. You can read our submission in full on our website 👇: https://lnkd.in/efu9-Wj9 Siobhán Dean Michael Kilkelly Karina Cassidy Lisa Goodman Audrey Devlin Eimear Curran

We were delighted that BPCI’s Eimear Curran had the opportunity to attend the launch of Ibec’s Irish Business EU Policy Priorities for 2024-2029.   The event was well attended by BioPharmaChem Ireland members including Johnson & Johnson Innovative Medicine Ireland's Fergus Sharpe, who chairs the BPCI Public Affairs and Government Affairs Working Group.   🔹 Speakers included the Commissioner-designate Michael McGrath, Ambassador Cait Moran, and senior officials from Ireland's Permanent Representation of Ireland to the EU.   🔹 “A workable EU Pharmaceutical Package and support for the General Pharmaceutical Legislation review and the new Chemicals Industry Package, as well as the affirmation that, “the EU must protect IP in strategic sectors, to incentivise innovation” were highlighted in EU Policy Priorities for 2024-2029   🔹 Heartening to hear leading Irish figures at EU level prioritise competitiveness, sensible levels of regulation for business and sustainability, all of which play a huge role in ensuring the continued success not just of our industry here in Ireland but in Europe.   🔹 ‘Competitive Business, Competitive Europe’ sets out Ibec’s vision for an EU that is focused on competitiveness, that unlocks the potential of the Single Market, that concentrates on EU added value, and that renews its commitment to openness. We want a more competitive EU that is a global leader in digital and AI transformation, supports innovation, leads in clean energy and is sustainable into the future.   🔹 The renewal of the EU institutions and Ireland’s Presidency of the Council of the EU in the second half of 2026 offer opportunities to strengthen our influence and to realise our vision for the EU. Read more about Ibec’s Irish Business EU Policy Priorities for 2024-2029 here: https://lnkd.in/e2a6ZeKE Sinead Keogh Siobhán Dean Karina Cassidy Michael Kilkelly Lisa Goodman

💼 The Expert Group on Future Skills Needs for the biopharma sector report, published earlier this year, forecast that a further 21,000 jobs will emerge in the industry by 2027. The Government must unlock the NTF and significantly increase investment in the HCI infrastructure and build HCI research capacity.     🔬 Paul Keogh from Takeda UK and Ireland is BioPharmaChem Ireland’s board sponsor for skills and talent, and representative on the Expert Group on Future Skills Needs for Biopharma Implementation Group.   You can read our #Budget2025 submission in full on our website 👇 :  https://lnkd.in/efu9-Wj9 #biopharma #Skills #Talent #LearningandDevelopment Sinead Keogh Siobhán Dean Michael Kilkelly Karina Cassidy Lisa Goodman Eimear Curran

Karina Cassidy is kicking off the recognised biennial BioPharmaChem Ireland #CMC #Regulatory affairs #training course for its members here in Radisson Blu Hotel & Spa Limerick. We have a full house here for the two day course, with this year's agenda covering key US and EU #legislation and #regulatory systems concerning drug and biologic approvals.   ✔ We will address common deficiencies in the Chemistry, Manufacturing, and Controls (CMC) section of applications, as well as navigate the complexities of post-approval changes.   📄 We'll also delve into the Common Technical Document (CTD) for drug substances and discuss EU variations through shared industry experiences. 🚛 Furthermore, we will explore the regulatory issues surrounding external manufacturing and supply chains.   #CMC #Compliance #Regulation #Biopharma   Sinead Keogh Siobhán Dean Michael Kilkelly Eimear Curran

There's still time to register for tomorrow's Empowering Diversity: Creating Inclusive Workplaces for People with Down syndrome #Webinar. The webinar, hosted in collaboration with MSD Ireland and Down Syndrome Ireland, will focus on MSD's new work placement initiative for people with Down syndrome at their Carlow site. You can register your place by signing up here https://lnkd.in/ddcmVezA and a link and instructions for joining will be sent to your inbox. 📅 Thursday 19th September ⏰ 11am - 12pm 🌐 MS Teams #empoweringdiversity #downsyndrome #diversityandinclusion Siobhán Dean Sinead Keogh Karina Cassidy Michael Kilkelly Audrey Devlin Eimear Curran

Our #Budget2025 submission outlines a path for Government to ensure that the industry remains a competitive global player and creates the conditions necessary for indigenous SMEs to grow and flourish.    You can read more on our website 👇 https://lnkd.in/efu9-Wj9  #SharpeningourEdge #Budget2025 #Competitiveness #Sustainability #BioPharmaChem Paul McCabe Sinead Keogh Siobhán Dean Michael Kilkelly Karina Cassidy Audrey Devlin Eimear Curran VLE Therapeutics

🔊 As organisations adapt to an ever-changing world, many are altering the structure by which they operate. To keep pace with increasing digitalisation and globalisation, some companies are adopting the Global Business Services (GBS) model, an organisational model where services are provided to the entire organisation through centralised, standardised processes with the aim of improved organisational performance. 💡 BPCI are inviting its members to a facilitated GBS Workshop, 10:30-13:30, 30 September, Ibec HQ, Dublin, as we discuss strategies to profile, support, strengthen and grow the Pharma GBS sector in Ireland. 👉 Register here: https://lnkd.in/ef66fGMb #GlobalBusinessServices #SharedServices #PharmaGBS

Only one week to go until the BioPharmaChem Ireland CMC Training Course but don’t worry there’s still time to sign up! The course will cover a range of topics from registration of #APIs, to common deficiencies in applications and variations, US pharmaceutical #legislation, submissions and post approval changes, to name but a few! 📅 24th and 25th September 2024 📍 Radisson BLU Hotel & Spa Limerick   A limited number of places are still available, members can register here: https://lnkd.in/e4vNU4ZZ #CMC  #Compliance #Regulation #Biopharma Karina Cassidy Siobhán Dean Sinead Keogh Michael Kilkelly Audrey Devlin Eimear Curran