Success 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.

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:

• Nicole (Niki) Gallo, Principal Consultant, Regulatory Affairs, Moderator
• Candice (Montagna) Durrence, Associate Principal Consultant, Regulatory Affairs
• Dan Smith, Associate Principal Consultant, Regulatory Operations
• Carolina Ahrendt, Principal Consultant, Program Leadership