ParticipACTION’s Post

An interesting local national development in Germany........

PIC/s Guide to Good Manufacturing Practice (GMP): manufacturing principles for medicines, APIs and sunscreens Published:: 14 June 2024 Newer version of PIC/S Guide to GMP Section 36 of the Therapeutic Goods Act 1989- external site (the Act) allows the Minister for Health and Aged Care to determine Manufacturing Principles - Therapeutic Goods (Manufacturing Principles) Determination- external site - that must be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients (API) and sunscreens, at Australian manufacturing sites. On 3 June 2024, the Determination was updated so that PIC/S Guide to GMP (01 February 2022), PE009-16 (PIC/S Guide to GMP version 16) applies. For therapeutic goods other than blood, blood components and biologicals, this means compliance with this guide, including the Annexes, other than: Annex 4 (Manufacture of veterinary medicinal products other than immunologicals) Annex 5 (Manufacture of immunological veterinary medical products) Annex 14 (Manufacture of medicinal products derived from human blood or plasma). This update: doesn’t change the status of Annexes 4, 5 and 14 includes clarifications to the existing Annex 13 includes a new Annex 16 (Authorised person and batch release). The guide applies to the manufacture of all medicines, APIs and sunscreens, unless exempt under provisions in the Act. Transition period for Annex 16 Annex 16 will apply to therapeutic goods manufactured from 3 September 2024. The transition period from 3 June to 2 September 2024 allows manufacturers to assess and plan for any changes needed to comply with Annex 16. Our expectation is that by 3 September 2024 manufacturers will have: completed their assessment of the impact of the Annex 16 on their operations completed updating quality systems documentation and implementing revised practices. https://lnkd.in/gUjTDs6p

The first of our guest blogs following on from our 'Invitation to Think' event. You can read more about the event here - https://lnkd.in/efRQvQPh

DEIB meet at Avantor with Noël France Sara Franzoni (She/Her/Hers) Avantor prioritizing diversity, equity, inclusion, and belonging (DEIB) by implementing various initiatives and strategies, such as: 1. Establishing diversity and inclusion training programs for employees and managers to raise awareness and foster understanding of DEIB issues. 2. Implementing recruitment and hiring practices that prioritize diversity and ensure equal opportunities for candidates from underrepresented groups. 3. Creating employee resource groups (ERGs) or affinity groups to provide support, networking, and advocacy for employees with shared identities or experiences. 4. Conducting regular assessments and surveys to gauge employee satisfaction and identify areas for improvement in DEIB efforts. 5. Implementing policies and practices that promote pay equity and address disparities in compensation. 6. Providing mentorship and sponsorship opportunities for employees from underrepresented groups to support their professional growth and advancement. 7. Engaging in community outreach and partnerships with organizations that support DEIB initiatives and contribute to positive social impact. 8. Establishing accountability measures and leadership commitment to DEIB goals, with regular reporting and transparency on progress. #avantorsetsscienceinmotion #DEIB #meetup #coimbatore

Last week, the Joint Select Committee on the Legalisation of Medicinal Cannabis in South Australia released its interim report; outlining a range recommendations reached via consensus between Labor, Liberal, Independent and Greens members.     The recommended shift away from a presence-based model to an impairment-based model aligns with contemporary medical practice and goes a long way in addressing the unjust targeting of medicinal cannabis users under current laws – particularly in relation to driving and WHS.     This transition is vital for enhancing public health and ensuring equitable treatment for all.     Here are some of the key recommendations:     Amendment of Road Traffic Laws: Ensure that driving with prescribed THC is not penalised if users are not impaired. Monitoring Impairment Assessment Technologies: Prioritise the introduction of accurate methods for assessing impairment. Worker Regulations: Allow workers using prescribed medicinal cannabis to perform their duties safely, provided they are not impaired. Uniform Standards: Develop consistent dispensing, transportation, and storage requirements for medicinal cannabis across Australia. Compassionate Access Support: Provide logistical assistance to ensure broader access to medicinal cannabis products.    As we advocate for a system that supports those in need, let’s continue to champion fairness and public health in our policies. While we in the Greens certainly believe that these reforms can, and should, go further, this is a good starting place.    You can find the full report here: https://lnkd.in/gPYUGb3a  

📣 The #RegionalInnovationValleys are selected! Commissioners Iliana Ivanova and Elisa Ferreira announced the 151 regions – including over 70 #ERRINmembers – at the European Committee of the Regions plenary session yesterday. The announcement was done one year after the launch of the call for expression of interest and the calls for proposals under EIE part of #HorizonEU and #I3Instrument of ERDF in 2023. Selected regions will now work to harness the potential of deep-tech innovation by enhancing the coordination and directionality of their R&I investment and policies towards key EU priorities, strengthening their R&I ecosystems and engaging in R&I collaboration with more and less advanced regions with complementary smart specialisations (#S3). We are thrilled to note that 73 #ERRINmember regions can now call themselves Regional Innovation Valleys. Congratulations to all our successful members, including regions of our Policy and Smart Specialisation Working Group leaders: Basque Country, Central Sweden European Office (North Middle Sweden and East Middle Sweden), Région Normandie, North-East Romania RDA - Brussels Office, Région Sud - Provence-Alpes-Côte d'Azur, Scotland Europa, Region Skåne (South Sweden), Regione Toscana and Wielkopolska. Among the 151 identified RIVs, 79 regions received the label based on answering the call for EoI and 72 regions are on track to become RIVs after successful participation in the calls for proposals – 15 projects will be granted a total of around EUR 116 million through the ERDF and Horizon Europe funding, and committed to co-fund another €77 million from private and public sources. Apart from funding, the European Commission aims to support these regions through community building activities, matchmaking events and targeted communication actions. New RIV calls under Horizon Europe with a total budget of EUR 40 million are expected in 2025! 💡 ERRIN has been closely following the RIV initiative, engaging in discussions and continuously supporting members in applying to the related calls through mapping, matchmaking and knowledge sharing activities, following high interest from the community. We look forward to offering opportunities for ERRIN members to share their RIV experiences and to support peer-learning among the 120 innovative European regions part of the network, as well as facilitate applying to the future RIV calls next year. ➡ Learn more and find the list of successful ERRIN member regions here: https://lnkd.in/d93m8FaS

The new year not only means new opportunities, but in the case of VGF also a new face. As of January 1, 2024, we said goodbye to Atty van der Schoot. After serving as director for more than ten years, she is now passing the baton to Joyce Wittelaar.   The VGF is no stranger to Joyce Wittelaar. She gained extensive experience in her previous positions at among others Incentive Travel Service and Rotterdam Partners, including the organization of conferences for international pharmaceutical companies and various (medical) association conferences. With her work as an External Affairs advisor for Erasmus MC, she left the industry behind, but continued to expand her network.   As the new director, she will set up meetings with all parties involved in the near future. Joyce: "I want to know what their experiences are and whether there are certain needs that we as VGF can do something about. The fact that I have been outside the industry for several years means that I can look at things with fresh eyes. But my enthusiasm and passion for the MICE industry never disappeared. I think it's great that I can pick that up again!" Interested in reading the whole interview with Joyce: https://lnkd.in/gn6TWP2y   At VGF we are looking forward working with Joyce!     Do you want to know more about what VGF can do for you? Visit https://lnkd.in/gasCGpt or feel free to contact Paul Gruijthuijsen via paul@vgfholland.nl.   #vgfisready #eventprofs #prefinancing #guarantee #conference #eventplanners #events #locationowners #reunite #MeetinNetherlands #NBTC #location #financialadvantage #evaluate #communication #network #planning #international #funding #tradeassociation #professionalization  

🌟 Embracing the Olympian Spirit: Unity Health Pharmaceuticals’ Journey to Success 🌟 At Unity Health Pharmaceuticals, we draw inspiration from the world of track and field and the rigorous training of Olympians to embody resistance, determination, and goal-setting in our quest for excellence. 🛡️ Resistance: Overcoming Challenges Just as Olympians face intense physical and mental challenges, we tackle obstacles in the competitive pharmaceutical industry with innovation and resilience. Our commitment to quality and safety remains unwavering in the face of adversity. 🔥 Determination: The Drive to Succeed Our relentless determination, fueled by a passion for improving healthcare, propels us to develop high-quality pharmaceuticals that make a difference in people’s lives. Every setback is an opportunity to learn and grow, reinforcing our dedication to our mission. 🎯 Setting Goals and Achieving Them: A Roadmap to Excellence Like Olympians, we set clear, measurable objectives to lead the pharmaceutical manufacturing sector, contribute significantly to Nigeria’s GDP, and enhance healthcare outcomes. Through research, strategic partnerships, and customer satisfaction, we turn our goals into achievements. Join us as we embrace the Olympian spirit, pushing boundaries and striving for greatness in every stride. Together, we can achieve extraordinary success and transform the pharmaceutical landscape in Nigeria and beyond. 🚀 #UnityHealthPharmaceuticals #OlympianSpirit #PharmaceuticalIndustry #HealthcareInnovation

VERY RELEVANT in TODAY'S AUSTRALIA

It's Autumn here in New Zealand, while it's Spring up North. Running clinical trials during specific seasons in New Zealand has some great perks, especially for our clients in the Northern Hemisphere. We can keep trials going almost all year round. When winter wraps up in the Northern Hemisphere, we're just getting started down here. Plus, different seasons mean different viruses and holidays. While they're soaking up the summer sun, we're tackling the winter flu season head-on. We also have a diverse patient population. From Māori, our indigenous people, to Pacific Islanders, Asians, Indians, and more, we've got a rich mix here in Auckland. That's a big win for research organisations looking for diverse patient data specific to our part of the world! To find out how Optimal Clinical Trials can deliver outstanding clinical research to accelerate your next clinical development program, head to https://lnkd.in/g37eigt3 #clinicalresearch #clinicaltrials