Skip to Content

The Quality Equation: Four Essential Components to Enable Drug Development Success

Watch The Quality Equation: Four Essential Components to Enable Drug Development Success

In the dynamic landscape of clinical trials, achieving quality excellence is paramount. To do so, it is crucial to identify and focus on the most significant risks and maintain a risk-based mindset throughout the trial’s lifecycle. This is not merely an important consideration; it is a critical one. The right approach to managing these risks can significantly affect the trial’s success. The FDA’s quality expectations now encompass the entire clinical trial lifecycle, requiring sponsors to be proactive and deeply involved from start to finish.

This webinar, titled “The Quality Equation: Four Essential Components to Enable Drug Development Success,” offers invaluable insights into how sponsor organizations can achieve quality excellence. The webinar delves into essential strategic components necessary for a sponsor to ensure inspection readiness and drive successful drug development. These components are pivotal for any organization aiming to meet the rigorous standards set by the FDA and other regulatory bodies.

The webinar highlights several critical areas of focus. First, it addresses the sponsor’s clinical organizational strategy, emphasizing the importance of a well-structured and comprehensive plan that aligns with regulatory expectations and the specific needs of the trial. A robust organizational strategy forms the foundation for effective trial management and oversight.

Next, the webinar explores risk-based trial management and oversight. This involves identifying potential risks early in the trial process and implementing strategies to mitigate these risks. By adopting a proactive risk management approach, sponsors can navigate the complexities of clinical trials more effectively, ensuring that potential issues are addressed before they become significant problems.

Quality compliance and assurance is another key component discussed in the webinar. Maintaining high standards of quality compliance throughout the trial is essential for meeting regulatory requirements and ensuring the integrity of the trial data. This involves regular monitoring and auditing processes to ensure that all aspects of the trial are conducted according to established protocols and guidelines.

Finally, the webinar emphasizes the importance of data integrity. In clinical trials, the accuracy and reliability of data are paramount. Ensuring data integrity involves implementing stringent controls and validation processes to ensure that all data collected during the trial is accurate, complete, and verifiable.

The speakers for this webinar are experts in the field, bringing a wealth of knowledge and experience.

Join us for this informative webinar to gain a deeper understanding of the quality equation and how to apply these essential components to your clinical trial process.

Halloran’s Inspection Readiness Methodology: Failure to Plan is a Plan to Fail

Watch Halloran’s Inspection Readiness Webinar Here

A Health Authority inspection of a clinical trial can occur at any point during a product’s lifecycle, making adequate preparation essential for a successful inspection and eventual market approval. Unfortunately, sponsors often begin preparing for inspections only when a critical milestone, such as a Biologics License Application (BLA) or New Drug Application (NDA) submission, is imminent. This last-minute approach can lead to stress, overwhelmed teams, and avoidable inspection findings, which may delay development milestones.

Effective inspection readiness goes beyond completing a checklist. Sponsors must embrace an inspection readiness mindset early in the development process by establishing and maintaining an ongoing, efficient system for compliance and preparedness. This proactive approach minimizes risks and ensures that the organization is always prepared for an inspection.

If you are seeking to adopt this mindset and enhance your inspection readiness, our upcoming webinar offers valuable insights. The session will cover:

Our expert panel includes Sheila Gwizdak, Vice President and Head of Consulting at Halloran Consulting Group, who will serve as the moderator. The speakers are Meaghan Marchand, Senior Specialist; Scott Rettig, Senior Specialist; and Laura Gilliam, Specialist, all from Halloran Consulting Group. They will share their extensive experience and practical tips to help you navigate the complexities of inspection readiness.

Join us to gain a deeper understanding of how to stay inspection ready throughout the clinical trial process and learn strategies to ensure your team is always prepared for an inspection, thereby enhancing the likelihood of achieving market approval for your product.

Successful Planning for an Original NDA / BLA Submission

This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate NDA/BLA journey effectively.

Watch our webinar!

By partaking in this webinar, attendees will have the opportunity to engage with our seasoned experts as they delve into successful planning strategies tailored for original NDA/BLA submissions. Drawing from their wealth of experience in regulatory strategy, regulatory operations, and program leadership, our experts will impart invaluable insights gleaned from recent NDA/BLA submissions. Furthermore, they will elucidate on indispensable tools and workstreams pivotal in facilitating clients to achieve seamless NDA/BLA submissions.

The webinar will cover a plethora of topics, ranging from pinpointing the trigger marking the commencement of NDA/BLA planning to adeptly orchestrating teams and resources. Additionally, crucial aspects such as navigating the submission process and leveraging the Electronic Submission Gateway (ESG) for upload will be meticulously addressed.

At Halloran, our unwavering commitment lies in making a tangible impact on human health. We share a common mission with our clients, striving to grant patients access to safe and efficacious innovative therapies tailored to address their unmet medical needs. Through this webinar, we aim to empower pharmaceutical professionals with the requisite knowledge and tools to facilitate the development and approval of groundbreaking therapies, thereby contributing to the advancement of healthcare on a global scale.

In essence, this webinar serves as an invaluable resource for stakeholders within the pharmaceutical industry, offering actionable insights and best practices crucial for navigating the intricate landscape of NDA/BLA submissions effectively.

Our Halloran Panelists Include:

Moving from Research to Development

The journey from research to development is a critical milestone for any biotech startup. This transition signifies the company’s progression from proving a drug’s potential efficacy to preparing for clinical trials, a pivotal step that underscores the startup’s early success. For many biotech or pharma leaders, especially those experiencing this shift for the first time, the process can seem daunting. Understanding what this transition entails and the requirements it imposes is essential for a smooth and strategic advancement.

In this webinar, our Halloran experts will delve into the nuances of moving from research to development. This phase is more than just a procedural shift; it involves a comprehensive transformation of goals, strategies, and team dynamics. We will explore the essential components of this transition, including the critical roles that need to be filled to ensure the process is efficient and effective.

Building a capable and knowledgeable team is paramount. This team will not only carry the project forward but will also navigate the complexities of regulatory requirements, particularly when preparing for an Investigational New Drug (IND) application to the FDA. We will discuss the various expertise needed on the team, from clinical trial specialists to regulatory affairs professionals, and how their roles contribute to the development pipeline.

Moreover, we will offer strategic insights on constructing a robust development roadmap. A well-defined roadmap is a blueprint that guides the project through each phase of development, from initial trials to final approval. It ensures that every step is meticulously planned and executed, reducing the risk of setbacks and accelerating the path to market.

Join us in this informative webinar to gain a deeper understanding of the transition from research to development. Learn from industry experts who will share their experiences and provide practical advice on building a successful development strategy. Whether you’re a seasoned professional or new to the field, this session will equip you with the knowledge and tools to navigate this crucial phase with confidence.

Implications of FDA’s Final Guidance on Informed Consent

Are you sponsoring a clinical trial and wondering how to develop an Informed Consent Form (ICF) that best facilitates the informed consent process? If you are, you’re not alone. If you aren’t, you should be. During our webinar, we will review the principles and requirements of informed consent, share common challenges and recommendations in the landscape of increasingly complex clinical studies, and unpack FDA’s final guidance on informed consent (August 2023).

The Halloran Team discusses strategies and tactics around the sponsor’s role in the new guidance on informed consent including:

Watch as our team unlocks the challenges and opportunities for sponsors to support sites in optimizing the consent process from a clinical, quality, and technology perspective. Walk away with actionable steps to improve the clarity, simplicity, and transparency of ICFs to improve participant experience and understanding.

Panel:

Karen Travers, Principal Consultant, Halloran
Krista Tibbs, Principal Consultant, Halloran
Laura Gilliam, Specialist Consultant, Halloran
Meghan Patterson, Senior Consultant, Halloran

YouTube Link here!