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Program Offerings for Student Attendees [clear filter]
Sunday, June 26
 

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

#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

10:45am 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
 
Wednesday, June 29
 

10:30am EDT

#323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-578-L04-P; CME 1.25; IACET 1.25; RN 1.25

A multiperspective, practical look at incorporating social listening into pharmacovigilance practices—including challenges, knowledge and guidance gaps, regulatory guidance, and recent research as well as experiential findings from both pharma and academia. Come hear some very up-to-date and practical learnings from social media in pharmacovigilance and be challenged to rethink some preconceptions about it.

Learning Objectives

Discuss current challenges and gaps in use of social media for pharmacovigilance including patient privacy, regulatory guidance, legal and reporter identification as global issues; Explain how some pharmaceutical companies have overcome some of those challenges to collect and analyze social media data to augment current postmarketing pharmacovigilance measures and where value has been found; Describe some findings from recent research efforts and data collection methods.

Chair

Laurie S. Anderson, PharmD

Speaker

Current Gaps and Challenges in Pharmacovigilance with Respect to Social Media
Lalitha P. Aiyer, MD, MBA, MS

A Real-World Look at Mining Social Media for Adverse Events: Impact of Regulatory Definitions and Methods
Michael A. Ibara, PharmD

Real-World Use of Social Listening for Pharmacovigilance Currently in the Pharmaceutical Industry
Lorrie Schifano, PharmD



Chair
avatar for Laurie Anderson

Laurie Anderson

Safety Evaluation and Risk Management Scientist, GlaxoSmithKline
Manager-Safety Evaluation and Risk Management Laurie joined GlaxoSmithKline in 2009 as a Medical Information Scientist. Prior to GSK Laurie worked as a clinical pharmacist at The University of California-San Francisco Medical Center and Duke University Medical Center. She earned her... Read More →

Speakers
avatar for Lalitha Aiyer

Lalitha Aiyer

President and Senior Medical Advisor, Medical and Pharma Advisors Group
Lalitha is a board certified physician with subspecialty training in Internal Medicine with 14 +years in clinical practice & over 15 years in the Pharmaceutical Industry. She runs an independent consultancy practice. Previously she worked in Ardea BioSciences as Head of Pharmacovigilance... Read More →
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
avatar for Lorrie Schifano

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session

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