What to Expect
This course provides an overview of the FDA structure and organization, regulatory history and current framework within the US for development of drugs, biologics, medical devices, dietary supplements and medical foods.
The course focuses on phase appropriate considerations and decision-making, roles involved in each stage, regulatory strategy and evolution, and agency meetings. General topics will cover all phases of the development process (including manufacturing, nonclinical and clinical development, and necessary compliance for each), options for effective and streamlined regulatory strategies that will be commercially successful, and product launch and marketing.
About the Chairperson
Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.
Head of Clinical Innovation
Chief Executive Officer
Managing Director, Life Sciences Strategy and Operations, R&D Practice
General Counsel & Chief Privacy Officer
Doctor on Demand
- Understand the historic evolution to the current framework for product development.
- Be able to identify the basic steps in pharmaceutical development.
- Gain hands-on experience of concepts and practical application of learnings.
- Learn key aspects and considerations in the regulatory processes.
- Understand key roles and responsibilities applicable to product development success.
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August 24th, 2020 | Day 1
8:00 AM - 8:30 AM
Registration & Login
8:30 AM - 8:45 AM
8:45 AM - 10:45 AM
FDA Scope & Organization
The scope of the FDA’s regulatory authority is very broad. With less than 8000 employees, FDA regulates approximately 60% of the GDP in the US, including food, drugs, cosmetics, and veterinary products. Learn the full extent and impact of their activities on your life personally and professionally, and how they organize to do so much with so few.
- Analyze FDA’s mission in its regulation
- Clarify FDA’s top regulatory priorities
- Understand how they organize to achieve their mission and meet their priorities
10:45 AM - 11:15 AM
11:15 AM - 12:15 PM
History of U.S. Regulation
The regulatory requirements for drug development are complex and intricate; however, they are navigable. This session will explore the historical underpinnings of our current regulatory framework and the current pathways to getting drug approval.
- Learn the submissions required for study and approval for your drug, device, biologic, medical food, or dietary supplement
- Ensure the use of the proper required format
- Overview of device regulations for IDE/510(k)/PMA
- Address biologics and biosimilars including IND/BLA
- Touch on dietary supplements and medical foods
12:15 PM - 1:15 PM
1:15 PM - 2:15 PM
History of U.S. Regulation (Continued)
2:15 PM - 3:15 PM
Special Programs to Consider
There are many FDA special programs available that offer different strategic advantages for your products. Learn about qualifying requirements and considerations you need to make for:
- Orphan drugs
- Breakthrough therapy designation
- Parallel review
- Fast Track
- RX to OTC switch
- Pediatric development
- Patient’s Right to Try
- Appreciate the history of how we got to where we are today
3:15 PM - 3:30 PM
3:30 PM - 4:30 PM
Special Programs to Consider (Continued)
August 25th, 2020 | Day 2
8:30 AM - 9:00 AM
9:00 AM - 9:15 AM
RECAP OF DAY ONE SESSIONS
9:15 AM - 10:45 AM
MEETINGS WITH THE FDA
To assist in navigating the intricate web of regulations and requirements, the FDA offers several key points of interaction during the development process.
- Specify which meetings are possible for your products during the development life cycle, and what you should aim to get out of them
- Plan how to take advantage of these meetings: from scheduling and planning, to conducting the meeting, to gaining full understanding and actionable output
- Review case studies of successful negotiation and communication during meetings
- Learn from less successful meetings, and how to manage and recover afterwards
10:45 AM - 11:15 AM
11:15 AM - 1:15 PM
BEGINNING WITH THE END TARGET IN MIND
The largest goal of every development program is to help patients and enhance their lives.
However, that cannot be accomplished philanthropically, so you have to consider what you
need to have at the end of the day in order to make money. So how do you ensure that you
will hit the target!
- What is a Target Product Profile (TPP) and how do you create it?
- One step beyond the TPP – the claims needed to resonate with customers
- Materializing the development plan from your targets
- Practical application exercise: turn a TPP into a development program
Joan A. ChambersThe Center for Information & Study on Clinical Research Participation (CISCRP)
Senior Director, Marketing & Outreach
Senior Vice President and Head of Pharmacoepidemiology and Risk Management
VIRTUAL LIVE-STREAM PRICING
Certification is becoming an important factor in the healthcare industry in general. A survey of over 1000 key opinion leaders (KOLs) found that over 90% preferred medical affairs professionals who had a Board Certified Medical Affairs Specialist (BCMAS) designation.
Several pharmaceutical companies also look at certification as a way to assess whether an individual possesses the skills and knowledge required for successful performance in a medical affairs role. Why are companies looking for this assurance? They want to hire the best of the best. By becoming board certified in your field of expertise, and by maintaining BCMAS, you are saying that you:
- Have met standards that have been established and verified by a credible, accrediting body.
- Are dedicated to maintaining quality of excellence in your profession.
These are powerful statements that speak volumes about you as a professional and the company or organization you represent. Board certification demonstrates that you are committed to your profession and that you want to continue to learn and grow.
Studies have shown that individuals who are certified in their field have higher salaries and better promotion opportunities.
Top 5 Reasons Why You Should Certify with the ACMA:
- Accredited: The ACMA is recognized nationally & internationally as a true mark of quality and excellence in the pharmaceutical industry for medical affairs professionals. The ACMA is accredited by the International Association for Continuing Education & Training (ANSI/IACET) which is the gold standard for certification & training around the world. Our program is administered and analyzed using the highest industry standards and state-of-the-art psychometric methodologies.
- Distinguish Yourself: Because ACMA offers multiple but related certificates, you can more readily become certified in more than one specialty, making you more valuable and marketable in the field.
- Go International: ACMA certification is widely accepted throughout the US as well as internationally with 25% of BCMAS graduates coming from outside the US.
- Expand Your Network: Once certified by ACMA you automatically become a member of the 75,000+ strong ACMA organization and gain access to a multitude of benefits, including discounts on continuing education, leadership opportunities, and access to a mentor to help you get ahead.
- Be on the cutting edge: ACMA board certification in medical affairs is the future of the life sciences and pharmaceutical industry.
Interested in BCMAS?
By attending any DGE/ACMA conference, receive 10% off of BCMAS registration.
Already BCMAS Certified? Receive 10% off your conference registration!