Regulatory Managers Boot Camp
Agenda
| Sunday, 23 October 2011 |
| 7:00–8:30 am |
Registration and Continental Breakfast |
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8:30–8:40 am
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Introductions and Schedule/Format Overview
Joyce Williams, RAC, FRAPS, principal consultant, ProFocus Regulatory Solutions
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8:40–9:30 am
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COMMUNICATION SKILLS
Effective Communication Tips and Why This is Important
- Cultural etiquette for global business
- Regulatory writing
- Presentations
- Influencing
Peggy Berry, MBA, RAC, vice president, regulatory affairs and quality, Amarin Pharmaceuticals
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9:30–10:00 am
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COMMUNICATION SKILLS
Emotional Intelligence
- Self management/adaptability
- Organizational capabilities
- Team building
- Problem solving
- Sustaining passion and vision
Louis J. Mazzarese , chief regulatory officer, Edwards Lifesciences |
| 10:00–10:30 am |
Refreshment Break |
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10:30–11:30 am
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MANAGEMENT SKILLS
Successful Management Skill Sets
- Teamwork
- Virtual Management
- Delegation and Coaching
- Time Management/Prioritization
- Performance Management
- Tips for Success as a First-time Manager, Middle Manager, and Senior-level Manager
Joyce Williams, RAC, FRAPS, principal consultant, ProFocus Regulatory Solutions
Talent Management
- Hiring and Coaching
- Employee Training and Development
- Mentorship Opportunities
- Performance Evaluation
- Resource Allocation
- Organizational Development and Succession Planning
Winifred C. Wu, MBA, FRAPS, RPh, founder & principal consultant, Strategic Regulatory Partners, LLC
Session Leader:
Joyce Williams, RAC, FRAPS, principal consultant, ProFocus Regulatory Solutions
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11:30–12:00 am
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ESSENTIAL KNOWLEDGE
Networking
- Why is networking important?
- How do you network effectively?
- What do you do with the collected information?
- How do you keep a current network?
- Techniques to practice
Peggy Berry , vice president, head of regulatory affairs and quality, Amarin Pharmaceuticals |
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12:00–12:45 pm
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Lunch
Challenge from Faculty: Network During Lunch
Goal: Meet at least three new people and consider their potential contribution to your contact portfolio.
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12:45–1:30 pm
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ESSENTIAL KNOWLEDGE
Ethics: What to Do When You're Faced with an Ethical Decision
- RAPS Code of Ethics and recent revisions
- Tools to deal with ethical dilemmas - case studies
Joy Frestedt, PhD, RAC, CCTI, president and chief executive officer, Frestedt Incorporated
Kim Fonda, manager, regulatory affairs & quality systems (acting), LifeScan Canada, Ltd.
Session Leader:
Lisbert Avila, RAC, regulatory affairs manager, HeartWare International, Inc.
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1:30–2:30 pm
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BUSINESS SKILLS
Financial Considerations for Regulatory Management
- Profit and Loss Statements Key financial approaches and tools
- Long range planning and annual planning
- Key budget elements
George Telthorst, MBA, director, Center for the Business of Life Sciences, Indiana University Kelley School of Business
Partner Relations
- Due diligence
- Legal considerations
- Working with marketing
Winifred C. Wu, MBA, FRAPS, RPh, founder & principal consultant, Strategic Regulatory Partners, LLC (tentative)
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| 2:30–3:00 pm |
Refreshment Break |
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3:00–4:15 pm
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LEADERSHIP SKILLS
Critical Leadership Skills
- Decision-making (Critical vs. Non-critical)
- Business strategy
- Regulatory intelligence
- Negotiation
Louis J. Mazzarese, chief regulatory officer, Edwards Lifesciences
- Leadership/coaching
- Influencing up/down/across the organization
Peggy Berry, MBA, RAC, vice president, regulatory affairs and quality, Amarin Pharmaceuticals
Session Leader:
Peggy Berry, vice president, head of regulatory affairs and quality, Amarin Pharmaceuticals
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| 4:15–5:00 pm |
Panel Discussion: Regulatory Career Pathways & Opportunities
- Strategies for advancing to management
- Top Three DO’s & DON’T’s
- Pharma vs. biotech vs. device
- Large companies vs. small companies
- Consulting independently or for a company
- Specializing vs. generalizing
- Switching pathways
- Professional Development Opportunities (e.g., RAC, speaking, etc)
- Industry vs. CRO vs. government
- Education, training
- Making career transitions
Session Leader:
Joyce Williams, RAC, FRAPS, principal consultant, ProFocus Regulatory Solutions
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5:00 pm
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Adjourn
Faculty will take questions and discuss advice one-on-one with attendees who wish to sign up in advance to discuss a specific career topic.
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