PPD Inc

Discover an informative webinar delving into the evolution of vaccine platform technologies to the current era of mRNA vaccines, with a discussion on the unique challenges they face in their advancements to clinical trials. The experts, Dr. Narendra Deshmukh and Dr. Kedar Purnapatre will discuss some of the many challenges facing the vaccine development industry today in the demonstration of product quality, immunogenicity and safety. They will share their experience working with various vaccine and adjuvant types emphasizing the importance of appropriately designed experiments, biomarker selection, and choice of appropriate bioassays and bioanalytical tools. Join this webinar to gain insights into the challenges and innovations in mRNA vaccines in clinical trials.

Discover a groundbreaking webinar delving into technology innovations in life sciences regulatory information management and their impact in the coming year. The life sciences industry has no shortage of technology trends, ideas and innovations that are on the horizon. Not to mention, within the regulatory information management space, there are changing rules and processes with which to stay compliant. Thus, which technology innovations will have the greatest impact in 2024? Technology platforms that embrace artificial intelligence (AI), such as the large language model-based chatbot ChatGPT, may transform all aspects of people’s lives for the better. The answer of course lies somewhere in between and the panelists will be discussing what’s behind, what’s ahead and what technology innovations organizations should pay attention to — and even plan to adopt — as they move into a new year. For anyone in life sciences who deals in regulatory information management and routinely engages with health authorities around the world, this webinar is focused on breaking down the hype around these innovations and sharing practical applications that can positively impact organizations. The panelists will discuss the trends attendees have heard about while attending industry conferences and events over the past year and highlight the innovations with real staying power that will still be discussed a year from now. The featured speakers will cover questions like: How can AI-driven automation and intelligent authoring use large language models (LLM) and forecast the likelihood of life sciences near-term implementation and the potential gains? On the flip side, what are the obstacles to turning vision into reality? (And many more.) Register for this webinar to prepare your organization for the remainder of 2023, find out which technology innovations in life sciences regulatory information management will have the greatest impact, and build your strategy for 2024 and beyond.

Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive and more predictable than getting US FDA clearance or approval. With the introduction of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the paradigm has shifted, and an increasing number of medical device companies are prioritizing the US market. However, the decision of where to launch first must be guided by more than just regulatory requirements. In an evolving global regulatory landscape where technology is advancing rapidly, medical device developers need to adopt a holistic approach to aligning their product development and go-to-market strategies to optimize the likelihood of regulatory and commercial success. In this webinar, the featured speakers will explore key considerations for prioritizing markets and optimizing the path to product launch. Join this webinar to gain insights into: - The comparison of the regulatory landscapes for medical devices and IVDs in the EU and US - Risk classification of medical devices and IVDs in the EU and US and its impact on product development and associated requirements - How to develop a rigorous clinical and regulatory plan to support your priority market - Guidance on aligning product development and go-to-market strategies - Real-world examples that bring these key considerations to life