The final version of the EMA revised Annex 1 was published on August 25, 2022, seven years after the revision process started. The revised annex becomes effective on August 25, 2023, except for section 8.123, which contains the requirement for lyophilisers that are manually loaded or unloaded with no barrier technology separation to be sterilised before each load, which becomes effective one year later, on August 25, 2024.
The final draft has 59 pages, which is dramatically longer than the 16-page 2008 version. This revision is a complete rewrite of the annex and was a joint EU, PIC/S, and WHO project, with US FDA personnel actively involved. The new Annex 1 revision must be implemented within one year of its issuance, by August 25, 2023.
The cGMP Annex 1 Workshop will feature industry experts who will provide practical solutions for implementation of the new guidelines at your organisation. These experts were intensely working on commenting and developing solutions for Annex 1 changes throughout the entire seven-year process since the publishing of the first draft of this virtually new guidance. They will provide a unique expertise on the gap issues you may have in your facility regarding Annex 1 implementation and can recommend a viable path forward. Attending this workshop will help your organisation avoid regulatory scrutiny and numerous observations.
The characterisation of extractables and leachables (E&L) for drugs, biologics, medical devices and drug-device combination products to ensure product safety has matured in the last periods, and today we all are waiting in anticipation for the publication of the ICH Q3E guideline on E&L.
Since more new and complex pharmaceutical manufacturing and delivery systems are progressing towards development, a variety of ongoing practical considerations and insights around E&L are accumulated, the current E&L regulations are evolving, and new regulatory requirements are coming.
The analytical, toxicological, and regulatory experts in the E&L area will elaborate on ensuring the safety, quality, compatibility, and regulatory compliance for drugs, biologics, medical devices, and combination products.
Explore technical presentations and practical case studies, participate in Q&As and interactive panel discussions, and leverage win-win strategies, perspectives, and partnership opportunities at the 4th Extractables & Leachables (E&L) Summit on May 10-11, 2023.
The gene and cell therapies clinical impact, production, and processes efficiency depend on the unique challenges related to CMC, analytical, process development, automation, manufacturing, facility design, aseptic processing, supply chain and others that developers of gene and cell therapies must resolve.
Key therapies experts, advisers, and practitioners will focus primarily on:
The #VLGeneCell brochure 2023 contains additional key insights as well as information about the concurrent #VLaseptic
The demand of aseptic manufacturing is rising, and, therefore, the challenges of aseptic processing will continue to grow in complexity.
The changes to Annex 1 are bringing new obstacles to pharma company operations that should be overcome from both technical and organisational perspectives.
At the 6th Aseptic Processing Summit on June 21-22, 2023, experts from the industry will highlight the requirements to robust aseptic processing, targeted implementation strategies, recent experience on establishing aseptic manufacturing processes for ATMPs and vaccines in particularly, and adoption of innovative aseptic processing technologies, including robotics.
The #VLaseptic brochure contains additional details and the key insights, as well as information about the concurrent #VLGeneCell.
The 5th Drug-Device Combinations & Sustainability Conference is a premier event that will bring together experts from the drug delivery field to discuss the latest developments and challenges in the regulatory environment for drug-device combinations and sustainability of products.
The conference will take place on September 27-28, 2023, in Düsseldorf, Germany, and will provide attendees with a unique opportunity to expand their knowledge and network with other professionals in the pharmaceutical industry.
Topics to be discussed include paperless submission, requirements, legislation, and the introduction of new products, all of which are crucial for staying up-to-date and prepared for the challenges of the coming year.
This conference will provide an excellent opportunity for attendees to gain a deeper understanding of the current situation in the field of drug-device combinations and sustainability of products, and to hear from leading experts in the industry.
Artificial intelligence (AI) is evolving autonomous driving, enabling commercial availability of semi-autonomous cars and advancing self-driving vehicles.
AI, machine learning, and neural networks are improving driving experience, vehicle’s safety, efficiency, and performance.
AI in automotive is in the early stage of development. The further advancements of AI-based autonomous cars will be concentrated on the building of safe and robust automated systems.
Automotive AI-related collaborations, partnerships, and acquisitions in the future will be accelerated globally.
Join the subject-matter experts at the #VLAIauto 2023 to explore the next generation AI for automated and self-driving vehicles.
Explore future developments in sustainability in the automotive industry at the Automotive Sustainable Material Solutions Online Conference on May 30, 2023. This event provides a holistic view of sustainable materials in the industry and inspires attendees to drive change towards a sustainable future.
The conference delves into the topic of circular economy in the automotive industry, including ways to design vehicles for disassembly and recycling, as well as closed-loop systems for materials such as plastics and metals. It will also cover advances in bioplastics and biofuels and their potential to reduce transportation's environmental impact.
Attendees will hear from expert keynote speakers, participate in interactive discussions and networking, see cutting-edge R&D, and learn about sustainable products and solutions. Professionals from across the automotive industry, including manufacturers, suppliers, researchers, and policymakers, are encouraged to attend this important discussion. Register now to secure your spot and be part of the drive towards sustainability.
Join our two-day live session and discover all the latest trends and developments in goalkeeping analytics, focussing on the best practices in goalkeeping science tools and strategies. Our company has garnered vast experience over the years, creating high quality conferences and summits that provide our participants with innovative ideas and useful connections. Our speakers will cover many topics across our two-day program diving into goalkeeping science, strength and conditioning, performance, and tactical analysis, as well as a special look at the youth development area.
Eager to learn about the top trends and strategies in sports science, strength and conditioning, performance, and tactical analysis, talent identification, youth development or scouting?
Join our live session and discover the latest trends and developments in hockey analytics and player development, focussing on the best practices in performance analysis and player development tools and strategies.
It is a dream for every C-Suite Executive to have an exceptional assistant who can be strategic in their thinking. Rather than having a mere secretary who can answer phones and do the expense reports, today’s Executives look for an assistant who can connect the dots and connect the people.
Today’s Assistant is an extension of their Executive. The 11th Global Executive Assistant Summit creates a knowledge platform for Assistants across the globe to accelerate their skills and learn from the best Executive Coaches, thought leaders, and iconic assistants.
Expand your knowledge on June 8th and 9th, 2023, at the 11th Global Executive Assistant’s Summit in Dubai