Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies.
For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents.Tools that incorporate generative artificial intelligence (AI) can be used to draft initial content from complex data sources.
By automating repetitive tasks and leveraging structured content, regulatory writing processes become more efficient and can lead to increased productivity. Regulatory writers can then focus more on demonstrating their value by aligning the content with key messages, ensuring consistency, and improving the quality of their regulatory documents.
Registration Fees & Deadlines
Free
Learning Objectives
- Learn how lean authoring techniques and technologies can streamline the regulatory writing process
- Learn how generative AI can distill complex source documents into contextually relevant regulatory content
- Understand why accelerating regulatory submissions requires combining writers’ deep subject matter expertise with assistive-authoring technologies
Who Should Attend?
Regulatory Writers Medical Writers Director, Medical Writing Regulatory Affairs Leaders Users of Regulatory Technology Project Managers Regulatory Submission Leaders
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Demetrius Carter, MBA, PMP
Senior Vice President, Regulatory Sciences & Medical Affairs, Certara
Demetrius Carter has 20+ years of drug development experience in the pharmaceutical and medical device industries. He previously worked at Glaxo SmithKline, Pfizer, and JNJ. Currently, he is the SVP, regulatory sciences and medical affairs at Certara Synchrogenix. Demetrius holds a BS degree in biological sciences from North Carolina State University and an MBA from Fairleigh Dickinson University. He also has several professional certifications, including Lean Six Sigma Green Belt, Project Management Professional (PMP) from PMI, Regulatory Affairs Certificate (RAC-US) from RAPS, and the Certified Profession (ACRP-CP) from ACRP.
Heather Graham
Vice President, Regulatory Science and Medical Affairs, Certara
Heather Graham started her career in the pharmaceutical industry nearly 20 years ago, and today she is the vice president of regulatory science and medical affairs at Certara. Her biopharma experience includes both large and small organizations, and she has successfully led a number of new medicines and vaccines to global approval in major markets (such as Canada and the US) in addition to developing markets where access to medicines can be more challenging. In her current role, Heather leads a global organization comprising more than 150 regulatory and scientific experts spanning 8 countries. She is passionate about patient centricity and advocacy in drug development, and has worked throughout her career to incorporate the voice and perspective of patients in the regulatory decision-making process. Heather is a certified executive and life coach with a passion for people-centered leadership, and nurturing and developing talent, including the next generation of women leaders in science.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org