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Featured Events

All agencies depend on building strong client relationships but in practice this is often quite challenging. Some relationships click, some don’t. This 3.5 hour workshop offers a very rigorous analysis of all the ingredients that build a robust, deep, long-term connection with clients. Who is the course for? Client-facing staff in any type of communications agency or consultancy. What’s covered? Developing your antennae – doing an audit One of the key themes of the workshop is around developing your ‘antennae’. Successful client-service managers may have different styles, but they all have antennae, sharply tuned to any little detail that could affect the relationship. During the workshop, participants audit the strengths and weaknesses in specific client relationships and develop a…



Events



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…


This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered. Why Should You Attend: All sterile products require some level of sterility during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet expectations or specifications can be critical from a regulatory and safety standpoint. You nee…
All agencies depend on building strong client relationships but in practice this is often quite challenging. Some relationships click, some don’t. This 3.5 hour workshop offers a very rigorous analysis of all the ingredients that build a robust, deep, long-term connection with clients. Who is the course for? Client-facing staff in any type of communications agency or consultancy. What’s covered? Developing your antennae – doing an audit One of the key themes of the workshop is around developing your ‘antennae’. Successful client-service managers may have different styles, but they all have antennae, sharply tuned to any little detail that could affect the relationship. During the workshop, participants audit the strengths and weaknesses in specific client relationships and develop a…

700, MassBio, Technology Square, Middlesex County, 02139, United States
Join us at the MassBioHub in Cambridge, Massachusetts (USA) on March 12, 2025 for this exclusive complimentary event and expert panel discussion showcasing the impact of unified trial design and regulatory strategies on derisking and accelerating clinical development. Registration: From 11:30 am Panel discussion:12:00 Post discussion lunch: 12:45-13:30 Secure faster development and regulatory pathways Biotech organizations face a series of high-stakes decisions as they design their clinical development programs. These decisions include trade-offs between factors such as speed and cost, as well as delivery and regulatory risk. In this balancing act, too often, companies default to traditional study designs and endpoints, often missing opportunities for innovative approaches that c…





This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers. Areas Covered in the Webinar: Regulatory Requirements for Quality Agreements Defining the Purpose of Quality Agreements Different Types of Quality Agreements with Service Providers Definition of Roles Between the Manufacturer and Service Providers Regulatory Roles in the Quality Agreement Expectations for Quality Agreements in Regulatory Inspections. Benefits of Quality Agreements from Both a Regulatory and Quality Perspective Enforcement of Quality Agreements Monitoring of Agreements. Wh…
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates. Learning Objectives: Which data and systems are subject to Part 11 and Annex 11 Computer Software Assurance impact on risk-based Impact of Electronic Systems… Clinical Investigations Q&A Guidance for Industry Oct 2024 Avoid 483 and Warning Letters Requirements for local, SaaS, and cloud hosting Reduce validation resources by using easy to understand fill-in-the-blank validation documents Areas Covered in the Webinar: What 21 CFR Part 11 means t…

