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Sunday, June 26
 

8:30am EDT

#21: Leadership: How to Organize and Lead People in a Work Group
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; PDU 3.25 PMI 2166-000163; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This tutorial addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.

Who should attend?

This tutorial is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and are interested in learning how to exert influence on group behavior, and for individuals to whom project managers report.

Learning Objectives

• Identify the different types of work group structures and be able to predict the quality of work the group will produce;
• Identify ways to correct dysfunctional group dynamics;
• Create and maintain cooperation among team members, including cross-functional teams.


Speakers
avatar for Michael Laddin

Michael Laddin

Chief Executive Officer, LeaderPoint
Mike Laddin is CEO of LeaderPoint. Mike has over twenty five years of senior management experience has a BS in Psychology Chemistry, MS in inPsychology and an MBA from Rockhurst University.LeaderPoint has over 700 clients including; 3M, ADP, Pfizer, Electronic Arts, LucasFilms, Zynga... Read More →


Sunday June 26, 2016 8:30am - 12:00pm EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 16: Prof Development, Tutorial

1:00pm EDT

#32: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial is designed to help you understand what culture, bureaucracy and innovation really are, and the impact they can have on actual business results — in concrete, clear terms. This requires stripping away the vagueness and assumptions that so commonly surround these topics. The discussion will include three primary components:
1) Understanding and influencing workplace culture and its impact on the results people get while working. Culture can either disrupt people’s ability to focus on the work, or it can reinforce and support clarity of focus, but culture is created by those working, not dictated by managers.
2) Avoiding and dealing with workplace bureaucracy, which almost always results from the creation of structure, a necessity as businesses and companies grow. Understanding and managing bureaucracy improves efficiency and economy.
3) Understanding and encouraging workplace innovation, and the direct benefits to efficiency and profitability that innovation brings about. Managers often attempt to drive innovation formally, but these efforts usually fail due to a lack of understanding what really encourages innovation at the work level — where it matters most.

Who should attend?

This tutorial is designed for designed for managers interested in directly impacting these three areas, generating greater business results through the efforts of others. It is designed for new and experienced managers seeking to understand and address these issues with planned deliberation.

Learning Objectives

• Define ways to create focus and direction for people in work groups or project teams;
• Identify an applicable set of tools to understand, diagnose and correct dysfunctional culture, bureaucratic inefficiency, and inadequate innovation.


Speakers
avatar for Michael Laddin

Michael Laddin

Chief Executive Officer, LeaderPoint
Mike Laddin is CEO of LeaderPoint. Mike has over twenty five years of senior management experience has a BS in Psychology Chemistry, MS in inPsychology and an MBA from Rockhurst University.LeaderPoint has over 700 clients including; 3M, ADP, Pfizer, Electronic Arts, LucasFilms, Zynga... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 16: Prof Development, Tutorial

2:45pm EDT

#001: Powerful Presentations
Limited Capacity seats available

Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Unlock the key to successful presentations in a powerful interactive workshop. Learn the critical elements to include and what to avoid in developing and delivering presentations in many different environments, and enhance your skills with practice.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss key skills for delivering successful presentations; Identify key communication mistakes to avoid during presentations; Practice presentation delivery skills.

Chair

Lynn King, MHA

Speaker

Facilitator
Karyn A. Lasky



Chair
avatar for Lynn King

Lynn King

Senior Director, Clinical Operations, TKL Research, Inc.
Clinical research professional with 24 years in the drug development industry working in large pharma, CRO and clinical site settings. 18 years experience in leadership and staff management. Certified trainer and professional coach with a passion for working with teams and creating... Read More →

Speakers
KL

Karyn Lasky

Director, Clinical Operations, TKL Research, Inc.


Sunday June 26, 2016 2:45pm - 4:00pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop

4:15pm EDT

#002: Networking: It's Personal - Understanding Yourself and Others to Maximize Personal Interaction
Limited Capacity seats available

Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Maximize your time at the Annual Meeting by getting a head start on networking skills. This workshop will address the value of networking, examining how to assess one’s own personality type, how an effective network needs a variety of personality types, and how to communicate effectively for personal and professional growth. Following the workshop, there will be an informal gathering at a local venue where you get to practice your new networking skills. This is a great way to meet other attendees and start off your week.

Would you like to attend this workshop? RSVP using this SURVEY LINK by June 3.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Identify personality traits of oneself; Identify personality types of others; Differentiate communication strategies based on personality type; Demonstrate how to optimize your network.

Chair

Chris Matheus, MBA

Speaker

Facilitator
Bob Muzerall



Chair
avatar for Chris Matheus

Chris Matheus

President, Matheus BD Connections LLC
Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a... Read More →

Speakers
avatar for Bob Muzerall

Bob Muzerall

Vice President, Sales & Sales Training, AMPLEXOR Life Sciences, LLC
Bob has held managerial and executive positions in the publishing and medical fields for over 30 years. He is currently Vice President, Sales & Sales Training at AMPLEXOR Life Sciences. AMPLEXOR Life Sciences helps the pharmaceutical, medical device and biotechnology industries launch... Read More →


Sunday June 26, 2016 4:15pm - 5:30pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Monday, June 27
 

8:30am EDT

#119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will introduce participants to the concept of narrative medicine and the skills and habits of reflective writing and listening in order to better recognize, receive, absorb, interpret, and honor stories of illness in a clinical setting.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Define narrative medicine; Explain how narrative competence is applied to nourish empathic health care professional-to-patient relationships; Apply the skills of close reading and reflective writing in a small group setting.

Chair

Jesus Rivera, MSc

Speaker

Facilitator
Lauralee Leonard



Chair
JR

Jesus Rivera

Senior Learning Manager, Bristol-Myers Squibb Company
Jesús is a seasoned learning and development professional with over 20 years experience diagnosing, planning and implementing training, organizational development and technology solutions that address the learning needs of global financial services and pharmaceutical organizatio... Read More →

Speakers
LL

Lauralee Leonard

Senior Scientific Writer, Bristol-Myers Squibb Company


Monday June 27, 2016 8:30am - 9:45am EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop

8:30am EDT

#120: DIA 2016: Student Forum
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: IACET 1.25

DIA offers students and emerging professionals a large number of networking and job hunting opportunities. This session will explore some of these opportunities in industry and in government agencies, and will also explore how DIA student chapter participation has helped students start their careers while participating in chapter events and opportunities.

Learning Objectives

Describe the role of student chapters in career starts; Identify industry career opportunities; Identify government regulatory career opportunities.

Chair

Danny Benau, PhD

Speaker

Government Positions: Opportunities, Considerations, and Processes for Federal Employment
Tammy J. Massie

DIA Student Chapter Membership as Part of a Career Springboard
Philip Masaitis

Opportunities in the Drug Safety Arena
Sameer Thapar, PharmD, RPh



Chair
avatar for Danny Benau

Danny Benau

Director, Biomedical Writing Programs, University of the Sciences
BA, Boston University, 1975; PhD, Boston University, 1984; MSOD, University of Pennsylvania; Wyeth Ayerst Research 1991 - 2001; Principal Scientific Writer; Freelance; Writing Consultant; Currently Associate Professor of Biomedical Writing University of the Sciences in Philadelph... Read More →

Speakers
avatar for Danny Benau

Danny Benau

Director, Biomedical Writing Programs, University of the Sciences
BA, Boston University, 1975; PhD, Boston University, 1984; MSOD, University of Pennsylvania; Wyeth Ayerst Research 1991 - 2001; Principal Scientific Writer; Freelance; Writing Consultant; Currently Associate Professor of Biomedical Writing University of the Sciences in Philadelph... Read More →
avatar for Philip Masaitis

Philip Masaitis

Student, Philadelphia College of Pharmacy, University of the Sciences
Currently pursuing a Doctor of Pharmacy degree at the Philadelphia College of Pharmacy, Phil has interned at GlaxoSmithKline Consumer Healthcare, serves as DIA Chapter President at the University of the Sciences, and was selected as the recipient of the 2016 DIA National Student Leadership... Read More →
avatar for Tammy Massie

Tammy Massie

Mathematical Statistician, Office of Equal Opportunity and Customer Outreach, National Institutes of Health (NIH)
Tammy Massie has worked as a mathematical statistician at various centers in the FDA for the past 13 years. In spring 2016, Tammy moved to NIH to perform statistical work on a variety of demographic subgroups within the Office of Equity, Diversity and Inclusion. Tammy recieved her... Read More →
avatar for Sameer Thapar

Sameer Thapar

Global Pharmacovigilance Director, Oracle HSC
Dr. Sameer Thapar is Oracle Health Science Consulting’s Director of Global Pharmacovigilance and concurrently Professor, Drug safety and Pharmacovigilance, in a Masters level program at a NJ University. As a subject matter expert in pharmacovigilance operations and compliance, he... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Session

10:00am EDT

Speaker Training Session
If you or a colleague would like to practice and receive some fantastic feedback and speaking advice, please stop by! Look for signs for the Speaker Training Room

Monday June 27, 2016 10:00am - 10:30am EDT
104A 104A

10:45am EDT

#142: Why We All Need Mentors (and How to Be a Good Mentor to Others)
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: IACET 1.00

Most who are fortunate enough to take an executive course return to the office filled with enthusiasm, ready to implement their new learnings. Unfortunately, the demands of the day job soon crush that enthusiasm. A mentor makes all the difference.

Learning Objectives

Discuss how having a good mentor can "up your game" continually; Describe what makes a good mentor including how they can help you succeed; Explore some of the tools, techniques and skills successful executive coaches use.

Chair

David B. Stein

Speaker

CRA Retention: Insider’s Perspectives on Interventions to Anchor a Tenured, Talented Workforce
Nadia Bracken



Chair
avatar for David Stein

David Stein

Independent eClinical Consultant, D. Bartley Consulting
David Stein is an eClinical Consultant with over 25 years of leadership and entrepreneurial experience ranging from successful start-ups and mergers and acquisitions to managing clinical technology product portfolios for several large companies. He has specialized in product strategy... Read More →

Speakers
avatar for Nadia Bracken

Nadia Bracken

Founder and Chief Connector, ClinOps Toolkit
Your go-to girl for superconnecting with clinical research insiders at ClinOps Toolkit in the Facebook and LinkedIn Groups.


Monday June 27, 2016 10:45am - 11:45am EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

9:40am EDT

#205: It’s Not You; It’s Me: Dealing with Team Challenges, Critique, and Criticism
Limited Capacity seats available

Component Type: Workshop
Level: Basic

The life science industry is dominated by teams. High-functioning teams create a dynamic where innovation and productivity flourish; however, even the most motivated teams can have challenging team members or be derailed by uninformative feedback, critique, and criticism. Obtaining team buy-in and actionable feedback can be challenging, especially while endeavoring not to appear defensive or strident. Initially, this session will outline specific team member personalities that can disrupt a project or process. Small groups will focus on strategies for keeping cool, obtaining information, and maintaining team rapport. Attendees will be encouraged to share their examples and solutions within their small group. This will be an interactive session for attendees at all levels.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the challenges of critique and criticism; Detail strategies for handling challenging team members; Strategize how to create a better rapport.

Chair

Robin Whitsell


Chair
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 20 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Tuesday June 28, 2016 9:40am - 10:25am EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#209: The Promotable Project Manager: Leadership Behaviors Critical to Success in the Life Sciences
Component Type: Workshop
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000187; RN 1.25

This workshop will facilitate the participants' examination of their own leadership behaviors and provide unique insight on how participants might develop new skills to expand their influence and impact.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe the results of new research on the leadership skills that lead to professional advancement of project and program managers; Explain how project and program managers can expand their influence and deepen their leadership impact when leading or managing life science projects.

Chair

Richard J Heaslip, PhD


Chair
avatar for Richard Heaslip

Richard Heaslip

Founder, Programmatic Sciences LLC
Rick Heaslip is the Founder of Programmatic Sciences LLC, a consultancy specializing in the development of highly effective project and program leaders. Rick often advises life science companies seeking to improve their abilities to lead and manage projects. Rick is also a faculty... Read More →

Tuesday June 28, 2016 10:30am - 11:45am EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Workshop

10:30am EDT

#210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000190; RN 1.25

This session will familiarize the audience with the Project Management Office (PMO), with a focus on the value added opportunities that a PMO can provide to your organization. Utilizing best practices and real-world examples, we will identify those PMO processes and tools that assist companies with achieving their project goals along with their overall portfolio strategies. This session will dovetail information regarding value added portfolio management, the effective utilization of processes and tools within a PMO, and the challenges of building a culture of innovation in project portfolio life cycle.

Learning Objectives

Define the role of a Project Management Office (PMO) and how it can bring value to an organization; Describe what a structured PMO can do in partnership with their functions; Discuss how to introduce incremental and radical innovation to drive the project portfolio and gain a competitive edge and accelerate growth.


Chair

Karen M. Marks

Speaker

What Value Can a Project Management Office Bring to Your Organization?
Kristin Fitzgerald, MBA, PMP

Best Practices for a PMO: Developing a PMO with Effective Processes
Karen M. Marks

Driving Innovation by Expanding the Role of Integrated Project Portfolio: Challenges and Best Practices
Dinesh Singh, MBA



Chair
avatar for Karen Marks

Karen Marks

Vice President, Global Program Management Office, Baxter International, Inc.
Karen Marks is the Vice President of the Global PMO for Baxter. Prior to joining Baxter, she has held positions in ConvaTec and Merck & Co and AT&T. Karen’s educational background includes a BS from Muhlenberg College in Human Resources Management, Master's Certification in Project... Read More →

Speakers
avatar for Kristin Fitzgerald

Kristin Fitzgerald

Director, Global Project Management, Project Management Office, Merck & Co., Inc.
Kristin Fitzgerald has been in the pharmaceutical industry for over 16 years and has worked in many different areas including, IT, Data Management, and Operations. In her current role, she manages support and leadership to Project Managers, Finance, and IT with respect to project... Read More →
avatar for Dinesh Singh

Dinesh Singh

Client Partner, Life Sciences, Cognizant
He is a seasoned advisor with 13 years of experience in business strategy, complex program management and large transformation/integration initiatives in life sciences industry. He has worked with leading pharmaceuticals clients to help them address key business problems and align... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166-000192; RN 1.00

This session will explore key aspects necessary for success when integrating regulatory operations teams as a result of mergers and acquisitions.

Learning Objectives

Discuss the necessary elements for successfully integrating regulatory operations departments during a merger or acquisition; Identify risks related to migrating information between systems; Respond to questions from others in the organization on best practices for integrating regulatory solutions.

Chair

Sarah Powell, RAC

Speaker

Challenges and Business Impact Associated with Mergers and Acquisitions
Meredith K Sewell

Building a Regulatory Information Management Capability for the Next Decade: People, Process, and Technology - Case Study
Dominique E. Lagrave



Chair
avatar for Sarah Powell

Sarah Powell

President, Powell Regulatory Services
Sarah has over 29 years of experience in pharmaceutical and related regulated industries. Most recently, Sarah has worked on assisting clients with projects related to process improvements, standards development, defining filing strategies and writing and review of submission content... Read More →

Speakers
DL

Dominique Lagrave

Director, Global Regulatory Affairs and Safety Operations, Amgen
Dominique has over 20 years of international regulatory affairs experience with the last 15 years spent in global regulatory operations management. Since 2015, Dominique is a Director at Amgen where he is leading the global regulatory operations organization with responsibility for... Read More →
MS

Meredith Sewell

Director, Global Regulatory Publishing, Allergan
Meredith Sewell is Allergan’s Director of Global Regulatory Affairs Operations and leads the Publishing, RIM and Archiving functions. Meredith joined the company in Irvine, CA in 2006 and in 2015, after Allergan merged with Actavis, Forest, Watson & Warner-Chilcott, she now leads... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model/Outsourcing, Session

2:00pm EDT

#251: Embracing Virtual Training Solutions in 2016: Focus on Performance!
Component Type: Workshop
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

In today’s global clinical research framework, delivering face-to-face training, is not always an option. This workshop explores the solutions that webinars and virtual classrooms provide for the stated learning objectives as well as the desired stakeholder performance outcomes after the training.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Differentiate between webinar and virtual classroom training delivery methods for investigator meetings, employee training and development; Discuss best practices, challenges and successes with webinar and virtual classroom instructional design, methods, and tools; Identify three attributes of webinars and virtual classrooms that promote employee engagement and learning, as well as the associated activities that support organizational performance goals.

Chair

Liz Wool, BSN

Speaker

Facilitator
Jim Bohlen



Chair
avatar for Liz Wool

Liz Wool

Global Head of Training, Barnett International
Liz Wool CCRA, CID, CMT, is Global Head of Training at Barnett International, an education, training and consulting company. Liz possesses 26 years in the product development industry and 37 years in the healthcare industry. Liz's expertise is in clinical research, operations strategy... Read More →

Speakers
avatar for Jim Bohlen

Jim Bohlen

Vice President, Business Development, Blue Sky Broadcast
Jim is responsible for business development and strategic partnerships for Blue Sky’s Life Sciences division. With over 15 years of experience in providing virtual meeting and eLearning solutions for investigator training programs, Jim has become a respected thought leader in the... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop

4:00pm EDT

#275: Creating a Competency-Based Onboarding and Learning Program on a Budget
Component Type: Workshop
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

The competitive talent landscape demands effective investment in onboarding and employee development. Workshop participants will design a departmental-level onboarding program and individual learning plan using an industry competency model.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Examine the life sciences industry competency model for organizational adoption and implementation; Identify approaches for development of a department-employee level onboarding program that is a right fit for the organization; Evaluate industry lessons learned in implementing individual employee learning plans-competency models.

Chair

Patterson Shafer

Speaker

Create an Onboarding Curriculum That Fits Your Budget
Liz Wool, BSN



Chair
PS

Patterson Shafer

Specialist Leader, Deloitte Consulting LLP
Pat is a specialist leader in Deloitte Consulting’s Life Sciences group with more than 30 years of consulting experience. During his career, he has led dozens of learning and development initiatives, including curriculum design, competency model development, running train the trainer... Read More →

Speakers
avatar for Liz Wool

Liz Wool

Global Head of Training, Barnett International
Liz Wool CCRA, CID, CMT, is Global Head of Training at Barnett International, an education, training and consulting company. Liz possesses 26 years in the product development industry and 37 years in the healthcare industry. Liz's expertise is in clinical research, operations strategy... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop
 
Wednesday, June 29
 

10:30am EDT

#325: Reinventing You: How to Change Your Career Fearlessly!
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: IACET 1.25

Hear from industry leaders on why they made a change and how they overcame personal/professional obstacles including new skills needed. Learn how these obstacles were overcome to make a "maybe" their reality, and determine if a change might be in your future.

Learning Objectives

Describe how various industry leaders made a significant change in their careers and the skills/thinking required to do so; Discuss how to interact with industry leaders to gain real-world and personal insights on what it takes to make a change; Explain what it takes to change one's career or plan to do so.

Chair

Kimberly Belsky, MS

Speaker

You’ve Worked a Long Time for a Sponsor, Now What?
Betsy Fallen, RN

Moving Within Pharma: Medical Affairs to Pharmacovigilance
Stephen Knowles

Through the Revolving Door: From Government to Private Practice
Heidi F. Gertner



Chair
avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →

Speakers
avatar for Betsy Fallen

Betsy Fallen

Consultant, BAFallen Consulting LLC
Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations... Read More →
avatar for Heidi Gertner

Heidi Gertner

Partner, Hogan Lovells US LLP
Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief... Read More →
avatar for Stephen Knowles

Stephen Knowles

Senior Director, Global Patient Safety, Medical and Benefit Risk Management, Eli Lilly and Company
Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Eli Lilly in 2001 and has worked in pharmacovigilance since 2005 in various roles in both the UK and USA. In his current role, Steve has management... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Forum

4:00pm EDT

#375: Creating Competent Clinical Research Professionals Through Systematic Evidence Review
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Understanding evidence-based systemic reviews requires not only foundational but also integrative, metacognitive skills. This session provides an overview of a successful, graduate-level how-to course as well as key practical takeaways for R&D.

Learning Objectives

Summarize role and importance of understanding evidence analysis for the R&D professional, including those headed for or currently in the pharmaceutical industry; Formulate the general structures of teaching evidence analysis to graduate students and strategies for tailoring to needs of students with widely varying background funds of knowledge.

Chair

Lisa Palladino Kim, MS

Speaker

Using a Meta-Analytic Method to Build Rigorous Thinkers for Clinical Trial Sciences
James Scott Parrott, PhD

CRO Perspective
Otis Johnson



Chair
avatar for Lisa Kim

Lisa Kim

Director of Capstone / Lecturer, Rutgers School of Health Professions, United States
Lisa Palladino Kim, is the Director of Capstone (Field Mentorship) and a Lecturer at Rutgers School of Health Professions MS in Clinical Trial Sciences Program. Lisa has 15 yrs of pharma expertise, concentrated in Clinical Ops (Pt Recruitment, Data Mgt, and Project Mgt), which allowed... Read More →

Speakers
OJ

Otis Johnson

Vice President, Feasibility & Clinical Informatics, ICON, Plc
16 years experience in the pharmaceutical industry, ranging from basic immunology research to scientific and operational aspects of clinical research and development. Holds an MPA in Health Policy and Management and a PhD in Management with a specialization in Leadership and Organizational... Read More →
avatar for James Parrott

James Parrott

Associate Professor, Rutgers, The State University of New Jersey
I have over 25 years of experience working as a methodological and statistical expert both within and outside the university setting in such areas as medical and healthcare research, international law, public health, evidence based medicine, childhood obesity, urban poverty, education... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Session

4:00pm EDT

#358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages
Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000183; RN 1.25

Strong communication skills are vital for effective collaboration and working in complex, matrixed environments. Yet dealing with conflict and delivering hard messages can be challenging and often uncomfortable for people at all levels in an organization. This workshop will explore scenarios routinely faced, such as: providing constructive feedback to a peer, delivering bad news to management, and dealing with poor behavior from a direct report. In this interactive forum, participants will be able to learn tips and become familiar with tools to help frame and deliver difficult communications, role play to pre-determined scenarios, receive real-time feedback and then apply the tools/tips to their own specific scenarios.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe strategies to assist in the communication of difficult messages to peers, direct reports, and senior leaders; Through role playing, demonstrate strategies and receive feedback on delivery of difficult messages.

Chair

Diane Neiman, MBA

Speaker

Facilitator
Karla Childers, MS



Chair
DN

Diane Neiman

Director, Global Project Management, Merck & Co., Inc.
Global Project and Alliance Management at Merck

Speakers
avatar for Karla Childers

Karla Childers

Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson, United States
Karla Childers is a Senior Director of Strategic Projects in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibilities are the Clinical Trial Data Transparency Initiative and the Johnson & Johnson Bioethics Committee.


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Workshop