EACH OF THE PUBLIC courses BELOW can be customized as in-house programs.
Please contact us DIRECTLY for more information.
TWO DAY Intensive Introductory Course - Introduction to OPDP
9/13/17 - 9/14/17 - SOLD OUT
12/6/17 - 12/7/17
A comprehensive introductory course for anyone new to the design or regulation of prescription drugs/biologics promotion. Professionals working in regulatory affairs, legal, medical, clinical research, marketing, sales, sales training, medical writing, communications, public relations, continuing medical education, or any other discipline related to marketing or regulating prescription drug/biologic products will find this course essential.
Topics covered include, but are not limited to:
Current regulatory/legal/compliance environment, DOJ/OIG interest in prescription drug promotion, OIG Compliance Guide and Pharma Code on Interactions with Healthcare professionals, FDA regulatory basics, fair balance, comparative claims, CME, disease state considerations, public relations considerations, medical conventions, launch campaigns, internet, DTC
The course will be held at the Philadelphia Downtown Marriott Courtyard on Juniper Street.
The hotel has reserved a small number of overnight rooms at a special rate. To make reservations please call Marriott Worldwide Reservations at 1-800-321-2211 or the hotel at 215-496-3200 and mention Lucy Rose and Associates, LLC – this course. Hotel accommodations and rates are subject to availability.
The course begins promptly at 8:30 AM and will end at 4:00 PM
Course includes breaks and lunch, as well as appropriate course materials. Transportation, hotel (if needed), and other meals are the participant’s responsibility. Participants may NOT receive a refund for any reason (unless LRA cancels course). If the participant cannot attend the course they may send a substitute. Course registration may be transferred to another participant at any time by notifying KATELUMPKINLRA@gmail.com prior to the start of the course.
To register please follow the two step process. First, fill out the registration form below and hit SUBMIT. Then click the PAY NOW button and follow the steps to pay and complete your registration.
Making Leadership: Executive Presence for Women
- 2017 TBD
Connection | Confidence | Charisma | Credibility | Clarity | Composure | Conciseness
This one-day leadership workshop focusing on building Executive Presence for Women is open to all women across the pharmaceutical, biologic, veterinary medicine, and medical device industries (and their supporting professionals, such as life sciences attorneys and advertising agency professionals) who are looking to strategically develop their leadership qualities and professional/personal growth potential. Consisting of no more than 15 women gathered from diverse sectors, the participants will engage in a one day highly engaging workshop focused around profession-targeted and FDA–related leadership exercises and conversations. Led by highly trained facilitators, Lucy Rose and Collier Lumpkin, this workshop will focus on personal branding, strategic networking, public speaking, and strengths-focused discovery, structured around real-life applications, in order to create a tool-kit for leadership success and transformational professional change in the life sciences.
About the Facilitators
Lucy Rose (MBA) is the President and founder of Lucy Rose and Associates, LLC. Known today as a global-leading advertising/promotion regulatory professional and entrepreneur, Lucy has also lead the Division of Marketing and Communications (FDA), the Office of Training and Communications (CDER – FDA), and a series of pharmaceutical sales teams. A lifelong leadership student and practitioner, Lucy has channeled her extensive learning into practice – developing exemplary change management initiatives, creating organization-wide orientation and development programs, and implementing game-changing crisis communication programs. An avid proponent of women’s leadership, Lucy structures her personal and professional life to provide ongoing mentoring and skill-based interpersonal and corporate development.
Collier Lumpkin holds a Masters degree in Higher Education and Leadership Development from The Ohio State University. A Gallup-trained StrengthsQuest facilitator, her work focuses on the intersection between strengths and development, both personally and professionally. Her primary research focuses on the specific strengths and challenges facing the Millennial generation, and the ways their life and work experiences are shaping the professional/corporate world.
Philadelphia Downtown Marriott Courtyard
21 N Juniper Street
Philadelphia, PA 19107
THE EMERGING LEADERSHIP WORKSHOP FOR WOMEN
- 2017 TBD
Inspiring Transformational Leadership through a Life Sciences/FDA Lens
This Emerging Leadership Workshop for Women is unique to the life sciences industry. Open to early-to-mid career women (less than 5 years direct experience) across the pharmaceutical, biologic, veterinary medicine, and medical device industries (and their supporting professionals, such as life sciences attorneys and advertising agency professionals) who are looking to strategically develop their leadership qualities and professional/personal growth potential, this workshop also strategically furthers participant understanding of the various regulatory authorities and the life sciences industry. Consisting of no more than 10 women gathered from diverse sectors, the participants will engage in a three-day immersive workshop focused around profession-targeted and FDA–related leadership exercises and conversations. Lead by highly trained facilitators, Lucy Rose and Collier Lumpkin, this workshop will focus on strategic development, deep network building, and professional discovery, structured around real-life applications, in order to create a tool-kit for leadership success and transformational professional change in the life sciences.
Through whole group strategy sessions, small group conversations, experiential learning activities, guided personal reflection, and strategic future planning exercises, this workshop will provide countless opportunities for tactical skill development and professional self-discovery.
Why should you participate in this innovative new program?
We realize that there are many leadership workshops to choose from. Yet with a specific focus on the distinctive realities facing the pharmaceutical industry, including industry interactions with regulatory authorities, the value to your future by attending this working is simply incalculable. Some of the many reasons to participate include:
- Three days of immersive learning – plus ongoing developmental suggestions/support, and networking/connection opportunities
- Opportunities to learn from diverse workshop members’ experiences in a small, safe environment of only 10 people
- Opportunities to develop numerous important skills for immediate application
- Strict adherence to workshop rules that prohibit discussion of confidential or competitive information, creating a safe environment for openness and discourse
Workshop Curriculum Overview
Using Practical job-related applications and FDA insights, participants will engage with the following topics throughout the three-day workshop:
Self-Awareness and Presence
- Maximizing Strengths awareness and applications
- Exploring Personal Branding strategies
- Balancing work and life consideration
- Creating individualized growth plans
Innovation and Vision
- Challenging the status-quo to create market success
- Building champions for professional achievement
- Overcoming professional fear and paralysis
- Leading from the communicated ‘why’
Communication and Clarity
- Enhancing professional presentation skills
- Enlarging strategic influence
- Creating integrated cross-functional teams
- Actively listening for the unspoken
- Maximizing meeting success
Strategy and Assessment
- Thinking strategically with mental flexibility
- Building powerful mentoring relationships
- Creating community support and mobilization
Courtyard Marriott New York Manhattan/Central Park
New York, NY
INTRODUCTION TO THE FOOD AND DRUG ADMINISTRATION
NO UPCOMING PUBLIC COURSES
Join us for an intensive and interactive one-day Introduction to the Food and Drug Administration course, limited to 25 people to create a safe environment and maximize personal engagement. This is an ideal orientation course for all new employees interacting with the differing aspects of FDA regulation. Understanding the organizational structure and regulation practices of the FDA is essential to comprehending the “why” behind your work contributions, how every piece of your work relates to the big picture for your organization, and how to maximize your work in relationship to others – both internally and externally.
Examples of topics to be covered in this course:
- Food and Drug Administration History
- FD&C Act
- Organizational Structure
- Interactions with other government agencies and with international regulatory agencies
- Specifics of FDA regulatory oversight
- Drug Development Overview by Phases (all phases, IND, NDA, etc.)
- Maximizing meetings with FDA (special emphasis on end of phase II meetings)
- Drug Review Process
- PDUFA, FDAMA, FDAA
- Advertising/Promotion requirements and review process
- Drug Safety considerations
- Manufacturing and Inspections (including international offices)
- Insights on working with FDA
This course is designed for all disciplines and from all industries who are impacted, either directly, or indirectly, by FDA regulation. Examples include:
Disciplines: Clinical, Regulatory, Legal, Medical, Marketing, Sales, Advertising, Administration, Project Management, Sales Training, Compliance, Trial Designers, Communications, Forecasters, etc.
US and International Businesses, Societies and Institutions: Pharmaceutical, Biotech, Medical Devices, Veterinary Medicine, Advertising Agencies, Public Relations Firms, Clinical Trial Firms, Insurance, Payers, Medical Societies, Academic Institutions, etc.
Philadelphia Downtown Marriott Courtyard
21 N Juniper Street
Philadelphia, PA 19107