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13: ProfDevelopment [clear filter]
Monday, June 17
 

2:15pm PDT

#143: Unveiling the Secrets of Success: An Executive Panel with Insights to Navigating your Career Journey
Component Type: Forum
Level: Basic

This forum is designed to inspire, provide insights for robust career planning, and targeted for anyone interested in further development regardless of the stage of their career. Join industry and executive leaders as they answer your career questions.

Learning Objectives

Describe how to approach career planning with a focus on experiences, transferrable skills, and cross-training; Discuss how to use mentoring relationships as a career catapult; Differentiate development from promotion/advancement and use that in career planning; Identify how to mentally deal with uncertainty and benefit from lateral moves and from keeping an open mind.

Chair

Leslie Sam

Speaker

Panelist
David Fryrear, MS

Panelist
Jeremy Jokinen, PhD, MS

Panelist
Paula Walker, MA

Panelist
Niam Vora, PharmD



Speakers
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
avatar for David Fryrear

David Fryrear

Executive Vice President and Head of Quality Assurance, Astellas, United States
David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Niam Vora

Niam Vora

Pharmacist, Srx Health Solutions, Canada
Niam Vora is a PharmD graduate from the University of Illinois Chicago. For the past two years, he has served as the National Student President for DIA Student Chapters across the United States. He has also completed a Schweitzer Fellowship, through which he implemented the United... Read More →
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →


Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  13: ProfDevelopment, Forum
 
Thursday, June 20
 

8:00am PDT

#409: Dive into the Power of Diversity: Leveraging Transferable Skills from Regulated Industries to Regulatory Agencies in Medicines Development
Component Type: Forum
Level: Intermediate

Curious about who shapes the decisions behind medicines approval and inspection? Wondering about the diversity in backgrounds and perspectives within regulatory agencies? Join us for an insightful session delving into the critical role of diversity in medicines development and regulatory decision-making. Ever pondered if your skills could transition you from being regulated to a regulator, or vice versa? Explore how transferable skills can bridge the gap between industry and regulatory roles, fostering diverse thinking essential for patient-centric outcomes. Discover career pathways in both sectors and learn how breadth of experience in seemingly unrelated roles can enrich regulatory processes, including patient advocacy. Don't miss this opportunity to uncover the less trodden path between regulators, the regulated, and patient advocacy. Join us to pave the way for a more inclusive and impactful medicines development landscape.

Learning Objectives

Recognize transferable skills from industry to regulatory roles, fostering diversity crucial for innovation; Assess the panelists' career trajectories transitioning between sectors, gaining strategies for professional growth; Identify the patient advocacy's role, understand how similar transferable skills are utilized to support patient-centric approaches.

Chair

Paula Walker, MA

Speaker

Panelist
Sophie Radicke, MSc

Panelist
Patroula Smpokou, MD



Speakers
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
avatar for Patroula Smpokou

Patroula Smpokou

Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States
Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →


Thursday June 20, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   13: ProfDevelopment, Forum
 

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