Events

This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach Description: The webinar will discuss in detail how to address the gaps between US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements for: Management responsibilities Device marketing authorization Facility registration Measurement, analysis & improvement Adverse events & vigilance reporting Design and development Manufacturing and service controls Purchasing activities Why Should You Attend: Companies conducting business in various geographical regions have to address numerous s…

Standard Operating Procedures (SOPs) are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training. Why Should You Attend: To learn the parameters of an effective SOP To distinguish a well-written SOP from a poorly written one To define processes better by effecti…

The marcus evans 19th Edition Project Portfolio and Resource Management Excellence for Pharma and Biotech conference taking place on 24-26 February, 2025, in Morristown, New Jersey, will bring together key industry leaders to explore the latest strategies to optimize the success of the portfolio and organization. Attendees will review novel and leading planning strategies and execution outcomes within project and portfolio management from their peers in an intimate and end user driven environment of networking, hands on demonstrations, and workshop / masterclass discussions. Attending This Premier marcus evans Conference Will Enable You to: Structure and simplify processes to maximize portfolio growth Balance financial & scientific value to ensure project portfolio alignment with stra…

The marcus evans 12th Edition R&D Controlling and Performance Management conference taking place on 24-26 February, 2025, in Morristown, New Jersey, will bring together key industry leaders to explore the latest strategies to optimise investments, streamline decision-making, and accelerate transformation in R&D. This event is your gateway to understanding how to drive efficiency, foster cross-functional collaboration, and refine R&D processes to stay ahead in an increasingly competitive landscape. Don't miss out on this opportunity to empower your R&D team with the tools and knowledge to thrive in a rapidly evolving market. Attending This Premier marcus evans Conference Will Enable You to: Achieve Operational Excellence in a Global R&D Organization Measure Objectives t…

With RNA technologies receiving the Nobel Prize two years running, we are witnessing the mRNA industry make great strides as optimized analytics, critical quality control methodology and robust assay development lead to efficient approvals and commercialization. However, developing, validating and transferring methods to demonstrate drug substance and product CQAs remains no easy feat, as knowledge gaps persist in phase appropriate potency assays, analyzing LNP payloads and novel cell-targeted delivery systems, controlling dsRNA, and navigating the global mRNA therapeutics and vaccine regulatory seas for approval in unmet patient need. For the very first time, the 4th mRNA Analytical Development and Quality Control Summit will unite the tightly knit assay development, analytical and qualit…

Investors in the cell therapy industry are actively looking into solid tumours, autoimmune indications and novel engineering as the best place to allocate their money and resources. This, along with the recent investments in Enara Bio, ArsenalBio, Kyverna and Artiva signifies that the field is poised to regain momentum. It's not just investments that are gaining traction. Recent approvals are changing the game, with Iovance and Adaptimmune making strides in treating solid tumours, Kite securing first-line treatment approval, and donor cell therapies, demonstrating success in putting autoimmune diseases into remission. The industry is brimming with new hope! The 8th CAR-TCR Summit Europe returns to London this February as your must-attend forum to remain on the pulse of recent innovation in…

Immune tolerance offers a transformative approach to autoimmune diseases treatment and holds the power to modify the course of disease progression and significantly improve the quality of life for patients. For 7 years, the 8th Antigen-Specific Immune Tolerance Summit has been at the forefront of innovative and novel approaches to immunology and inflammation and facilitated the development of new industry connections, research partnerships and seed investment across the immune tolerance field. In 2025, this highly anticipated meeting will delve further into the complex reality of inducing immune tolerance as the landscape evolves with Diamyd, Annokion, COUR and more being the custodians of rapidly progressing clinical tirals. From antigen selection, to establishing biomarkers of tolerance…

The radiopharmaceutical race is on and pharma leaders such as AstraZenca, BMS , Eli Lilly, Novartis and Sanofi are not getting left behind. Bolstering discovery pipelines through acquisitions of preclinical Mariana Oncology, Radionetics and Aktis Oncology, the field is turning to cutting-edge, novel targeting molecules and new targets to address more unmet medical need. With strong clinical efficacy from blockbuster drugs Pluvicto and Lutathera, radiopharmaceutical leaders are looking for the next application of this highly efficacious and potent modality! The inaugural Targeted Radiopharmaceuticals Target Selection and Drug Design Summit is your dedicated forum to advancing novel radiopharmaceutical drug discovery. Delve deep into target mining, screening, discovery and selection from ROR…

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training. To accomplish these goals, we will review regulato…

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system. Why Should You Attend: An effective change control system is one of the cornerstones of a productive organizational quality system. Change control can be instrumental in ensuring continuous control over changes to facilities, equipment, processes, specifications, and laboratory operations, etc. The importance of change control is emphasized by how it is stressed in regulatory inspections (FDA, EU, TGA, etc.) and in regulatory requirements. There are specific change control elements in cGMPs, ICH, and ISO requirem…

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations. Why Should You Attend: This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. Areas Covered in the Webinar: Which data and systems are subject to 21 CFR Part 11 and Anne…

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits. Why Should You Attend: There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. And business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate,…

Embark on a transformative journey at the prestigious 8th Edition of the International Conference on Materials Science and Engineering, poised to take place in the enchanting city of Rome, Italy, and virtually from March 10 - 12, 2025, themed "Materials for Tomorrow: Advancements in Materials Science & Engineering" Esteemed scholars, researchers, academics, industry mavens, and enthusiasts from around the world are warmly invited to engage in this dynamic symposium, fostering interdisciplinary collaboration and the exchange of insights. Venture into the expansive realm of materials science and engineering, where innovation knows no bounds. Explore a diverse array of materials, from cutting-edge polymers to revolutionary biomaterials, each offering unique applications across various sec…

China’s Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China’s NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products. Why Should You Attend: China has been improving its’ regulatory regime governing the food and pharmaceutical industry in recent years. By promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, as well as importers, it will be important to pay close attention to the pace at which NMPA implements these changes. This course specifically focuses on the overall regulatory compliance requirements and procedu…

2024 has revitalized the bacteriophage field, with over $9 Million invested into BiomX and Locus Bioscience; $24 Million dedicated by BARDA to progress bacteriophage therapies to Phase II trials; and the release of further regulatory guidelines by agencies. The advancement to the clinic has resulted in a wealth of data available to investigate the function, genetic modification, and safety of bacteriophages. However, the lack of clarity on the pathway to the market with a sustainable and strategic commercial strategy means that biopharma companies need to rethink their business model to ensure they are sustainable. At the 7th Bacteriophage Therapy Summit, we'll be diving into the regulatory and investment landscape for drug developers, clinical updates showing efficacy, utilizing machine l…

As the cell and gene therapy (CGT) pipeline matures and new, exciting technologies scale into the clinic, the success of delivering the growing number of complex CGTs to patients in a safe and timely manner relies on robust and resilient global supply chains. Join the 6th Supply Chain and Logistics for Cell and Gene Therapies Summit for the ultimate practical guide on designing and implementing scalable, traceable, and resilient global supply chains. For the first time, this forum will cover the full breadth of end-to-end supply chain challenges across both cell and gene therapy, bringing leading voices across autologous, allogeneic, in vivo, and ex vivo programs. Leading clinical and commercial drug developers, trusted service providers, and expert clinical sites will lend solution-led ca…