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
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:
- Implications of FDA’s final guidance on informed consent
- ICF format and delivery best practices
- Proactive considerations for patient comprehension beyond the written ICF
- Communicating new risks, benefits, or changes during an ongoing study
- Adapting consent approach to the target population, particularly vulnerable populations Communicating trial role and expectations with compassion and honesty
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 informed consent forms 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
