Events
Featured Events
This two day course is designed to help you develop your communications skills to help you impact, influence and inspire. We believe that anyone can be taught these skills, it’s simply a set of tangible behaviours that can be replicated and integrated into our everyday lives and when used properly can help build your confidence, enhance and sustain your long-term relationships and motivate others to make the most of their potential. Influencing and inspiring is often about how we make others feel and how we can take control of a situation. Through learning a set of simple, practical techniques and behaviours you’ll be able to transform the way you communicate. It’s all about bringing out the best version of yourself. It’s that secret ingredient you need (and can learn) to make sure that yo…
This course is delivered online via Zoom in 1 day from 10am – 12:30pm. About the trainer Emma Georgiou has over thirteen years’ of leadership experience in healthcare communications, working in-house at agencies, and in a freelance consulting capacity. Most recently, Emma was the Executive Director of a not-for-profit health policy consultancy, developing award-winning healthcare initiatives in areas of unmet need to reduce health inequalities, drive behaviour change and influence health policy. Emma is also an EMCC-accredited coach and works with individuals and organisations to build resilience, improve performance and create happier, more cohesive teams. Course preparation There will be a short pre-programme questionnaire comprising five questions to complete and provide a few days in a…
This course is delivered online via Zoom over 3 days and is highly interactive. About the trainer Emma Georgiou has over thirteen years’ of leadership experience in healthcare communications, working in-house at agencies, and in a freelance consulting capacity. Most recently, Emma was the Executive Director of a not-for-profit health policy consultancy, developing award-winning healthcare initiatives in areas of unmet need to reduce health inequalities, drive behaviour change and influence health policy. Emma is also an EMCC-accredited coach and works with individuals and organisations to build resilience, improve performance and create happier, more cohesive teams. Course preparation There will be a short pre-programme questionnaire comprising five questions to complete and provide a few…
Molecular glue development continues to thrive, offering exciting opportunities to target previously undruggable proteins and treat a wide range of diseases. 2024 has seen a multitude of collaborations, with Takeda and Degron Therapeutics entering a deal worth $1.2 billion.
The 3rd Molecular Glue Drug Development Summit returns as the only industry-dedicated forum bringing together 90+ experts as they showcase the latest advancements and breakthroughs in molecular glue drug development through discussions and data-driven case studies on screening tools, novel mechanisms of actions of proximity-based degrading and non-degrading molecular glues and lead optimization strategies, to streamline discovery and development of safe and effective glues.
URLs:Website: https://ter.li/eu7mbjTickets: ht…
As innovative drug delivery platforms beyond GalNac continue to emerge and novel chemical modifications are discovered, the potential for RNAi therapeutics to treat a plethora of diseases grows. Now more than ever, RNAi therapies hold promise to treat diseases beyond the liver and provide efficacious, tolerable treatment options for patients.
The 6th RNAi-Based Therapeutics Summit is returning to Boston to showcase the latest delivery technologies, data from clinically successful extra-hepatic targeting, cutting-edge AI tools to assist payload design, and breakthrough chemical modifications which enhance stability, allowing for precise therapeutic delivery.
Uniting 70+ leaders of the RNAi world, this Summit will empower experts to pioneer their RNAi candidates into clinically successful th…
Waves of new models are being validated. A wider industry shift to precision oncology is requiring more specific genetic models. Availability and cost-effectiveness of sequencing and computational tools are enabling better and more accessible characterization of therapeutic pathways than ever before. The challenges and opportunities in preclinical and translational research are constantly evolving, and it has never been more critical to benchmark and share cross-industry learnings and case studies to de-risk the move to the clinic.
Reuniting 180+ Preclinical, Translational, Discovery, Pharmacology, and Biology experts to share case studies in improving target selection, facilitating biomarker discovery, and achieving clinical translatability, the 9th Tumor Models San Francisco Summit is th…
Events
09-Jan-2025 - 09-Jan-2025
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations. Why Should You Attend: One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA continues to find fault with investigations and the stated conclusions. The FDA clearly expects that deviation investigations determine what happened, why it happened, and what was done to prevent it from happening again. Investigations also receive detailed scrutiny during FDA inspections. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all ar…
13-Jan-2025 - 13-Jan-2025
In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body. Why Should You Attend: The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the supply chain and the interfaces to the EN ISO 13485:2016. Both, the ISO standard and the MDR requires for outsourced processes additional activities and be careful with outsourced processes. Those are not only on the classic supplier side. Those are also on the other side of the company in the area of sales and post m…
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers. Why Should You Attend: Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO. This webinar will provide a thorough understanding of the content that…
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time. Why Should You Attend: This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data. Areas Covered in the Webinar: Avoid 483s and Warning Letters. Ensure compliance with 21 CFR Part 11 when using Excel spreadsh…
Pharmaceutical packaging and labeling play a pivotal role in the success of any product launch. These activities serve as the essential link between product development and its delivery to the market while ensuring compliance with stringent regulatory requirements. Despite their critical nature, packaging and labeling processes are often overlooked during the planning stages, leading to prolonged cycle times, costly mistakes, delayed product availability, and potential recalls due to noncompliance. This training offers a comprehensive overview of packaging and labeling within the broader context of product development. It equips participants with the knowledge and tools to enhance operational efficiency, reduce errors, and ensure compliance, ultimately contributing to a product's market su…
This two day course is designed to help you develop your communications skills to help you impact, influence and inspire. We believe that anyone can be taught these skills, it’s simply a set of tangible behaviours that can be replicated and integrated into our everyday lives and when used properly can help build your confidence, enhance and sustain your long-term relationships and motivate others to make the most of their potential. Influencing and inspiring is often about how we make others feel and how we can take control of a situation. Through learning a set of simple, practical techniques and behaviours you’ll be able to transform the way you communicate. It’s all about bringing out the best version of yourself. It’s that secret ingredient you need (and can learn) to make sure that yo…
This course is delivered online via Zoom in 1 day from 10am – 12:30pm. About the trainer Emma Georgiou has over thirteen years’ of leadership experience in healthcare communications, working in-house at agencies, and in a freelance consulting capacity. Most recently, Emma was the Executive Director of a not-for-profit health policy consultancy, developing award-winning healthcare initiatives in areas of unmet need to reduce health inequalities, drive behaviour change and influence health policy. Emma is also an EMCC-accredited coach and works with individuals and organisations to build resilience, improve performance and create happier, more cohesive teams. Course preparation There will be a short pre-programme questionnaire comprising five questions to complete and provide a few days in a…
This course is delivered online via Zoom over 3 days and is highly interactive. About the trainer Emma Georgiou has over thirteen years’ of leadership experience in healthcare communications, working in-house at agencies, and in a freelance consulting capacity. Most recently, Emma was the Executive Director of a not-for-profit health policy consultancy, developing award-winning healthcare initiatives in areas of unmet need to reduce health inequalities, drive behaviour change and influence health policy. Emma is also an EMCC-accredited coach and works with individuals and organisations to build resilience, improve performance and create happier, more cohesive teams. Course preparation There will be a short pre-programme questionnaire comprising five questions to complete and provide a few…
The marcus evans 26th Edition Strategic Project & Portfolio Management for Pharma conference taking place on 27-29 January, 2025, in Frankfurt, Germany, will bring together key industry experts to discuss how to maximise the value and resilience of your portfolio by adopting best practices in project prioritisation, resource allocation, and robust portfolio governance. During the conference, you will learn how to implement advanced data management and consolidation tools that enhance decision-making and tricks to ensure that your projects align with strategic objectives. Additionally, you will explore how AI can help pharmaceutical companies adapt to geopolitical challenges and optimise their PPM strategies for better outcomes.
Attending This Premier marcus evans Conference Will Enable…
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time. Why Should You Attend: Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to have them designed such that they are easy to maintain and update. This webinar will instruct the participants how to write, maintain, an…
Molecular glue development continues to thrive, offering exciting opportunities to target previously undruggable proteins and treat a wide range of diseases. 2024 has seen a multitude of collaborations, with Takeda and Degron Therapeutics entering a deal worth $1.2 billion.
The 3rd Molecular Glue Drug Development Summit returns as the only industry-dedicated forum bringing together 90+ experts as they showcase the latest advancements and breakthroughs in molecular glue drug development through discussions and data-driven case studies on screening tools, novel mechanisms of actions of proximity-based degrading and non-degrading molecular glues and lead optimization strategies, to streamline discovery and development of safe and effective glues.
URLs:Website: https://ter.li/eu7mbjTickets: ht…
As innovative drug delivery platforms beyond GalNac continue to emerge and novel chemical modifications are discovered, the potential for RNAi therapeutics to treat a plethora of diseases grows. Now more than ever, RNAi therapies hold promise to treat diseases beyond the liver and provide efficacious, tolerable treatment options for patients.
The 6th RNAi-Based Therapeutics Summit is returning to Boston to showcase the latest delivery technologies, data from clinically successful extra-hepatic targeting, cutting-edge AI tools to assist payload design, and breakthrough chemical modifications which enhance stability, allowing for precise therapeutic delivery.
Uniting 70+ leaders of the RNAi world, this Summit will empower experts to pioneer their RNAi candidates into clinically successful th…
With GSK's €1.4Bn investment into acquiring CureVac's infectious disease pipeline, Moderna and BioNTech's initiation of personalised cancer vaccine trials, and the emergence of novel mRNA applications in protein replacement therapy, gene editing and in vivo cell engineering, the mRNA industry is observing huge value R and D opportunities that will open the floodgates towards clinical and market approval in 2025.
The 4th mRNA-Based Therapeutics Summit Europe returns to Frankfurt, Germany as the industry's premier forum dedicated to showcasing the hottest disease targets, never-before-seen pre-clinical and clinical data, and demonstrating key routes to commercial success for mRNA therapy and vaccine R and D pipelines.
Whether you're entering the mRNA arena for the first time or a well-season…
Waves of new models are being validated. A wider industry shift to precision oncology is requiring more specific genetic models. Availability and cost-effectiveness of sequencing and computational tools are enabling better and more accessible characterization of therapeutic pathways than ever before. The challenges and opportunities in preclinical and translational research are constantly evolving, and it has never been more critical to benchmark and share cross-industry learnings and case studies to de-risk the move to the clinic.
Reuniting 180+ Preclinical, Translational, Discovery, Pharmacology, and Biology experts to share case studies in improving target selection, facilitating biomarker discovery, and achieving clinical translatability, the 9th Tumor Models San Francisco Summit is th…
05-Feb-2025 - 07-Feb-2025
Scripps' Structural Heart Intervention and Imaging conference is designed to provide a practical, cutting-edge, and live case-based assessment of structural heart disease interventions and cardiovascular imaging. The course will place a strong emphasis on the collaborative nature of these procedures across many disciplines within cardiology. Expert faculty will include interventionists, invasive cardiologists, echocardiologists, electrophysiologists, cardiothoracic surgeons, cardiac anesthesiologists, and sonographers. Faculty will discuss clinical guidelines on patient selection, pre-procedural assessment, procedural tips, techniques, and challenges (including concurrent imaging) during the performance of the procedures and conclude with assessment of outcomes and future directions.
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05-Feb-2025 - 05-Feb-2025
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach). Why Should You Attend: This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase producti…
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF. Why Should You Attend: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you understand in detail the new requirements for trial master files (TMF). Areas Covered in the Webinar: Trial Master File (TMF) background and rationale The essential documents to include in a TMF Orga…
Critical Issues America2025 Annual Conference - February 7-8, 2025The meeting will help participants to identify and manage complications associated with endovascular and open repair of complex aortic disease including: arch descending thoracic, TAAA, pararenal and juxtarenal aneurysms, aortoiliac aneurysms and other miscellaneous pathologies affecting the aorta.
CIA will recognize potential treatment failure and the role of advance imaging techniques in the evaluation, treatment, and management of aortic disease.
The target audience includes physicians who specialize in vascular surgery, cardiology, interventional radiology, vascular medicine, cardiothoracic surgery, as well as fellows, and allied health professionals.
Objectives:Provide an overview of current and unmet management of DLE…
10-Feb-2025 - 10-Feb-2025
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence. Why Should You Attend: This course will address how to write effective correspondence and reports in support of your company's activities. Attendees will learn how to organize and deliver information for the intended audience. They will also learn how to write clear and readable documents, and h…
This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98. Why Should You Attend: Reusable medical devices continue to receive scrutiny from regulatory agencies both in the United States and internationally. Since the advent of ANSI/AAMI ST 98 there has been more clarity in how to perform these validations but it is still important to know the regulatory expectations to reduce the likelihood that submissions will not be accepted and require additional testing or worst case that the testing needs to be repeated. This presentation will address the most current expectations for cleaning validations of reusable medical devices that are performed in support of th…
