18 August 2016
5:30–8:30 pm
Abbvie Inc.
North Chicago, IL
In 2016, we as regulatory affairs professionals find ourselves in a unique position to be strategically valuable to our employers by having the necessary knowledge related to combination products. The increase in the development of simple and complex combination products during the past five years has accelerated.
This program will touch upon current regulatory framework for combination products, anticipated changes in the various regulatory jurisdictions and strategic value of combination products and associated regulatory knowledge. You will be able to interact with two experienced regulatory executives and ask questions related to this exciting regulatory topic. This program has been set up to be both instructive for professionals in the RAPS track and highly interactive for the more experience regulatory professionals.
Are you ready when your senior management calls upon you for a combination product regulatory strategy? Attend this exciting program and make sure you are. This program has been designed to engage all levels of the RAPS career ladder.
Upon the program’s conclusion, you will be able to:
- Understand the terminology, current regulations and strategic considerations necessary for combination products.
- Understand the career track for regulatory professionals with combination product experience.
- Understand the GxP and regulatory submissions requirements for combination products.
Who Should Attend?
- Regulatory affairs and quality professionals
- Research and development professionals
- Life science industry executives interested in learning more about combination products
Date/Time:
Thursday, 18 August 2016
5:30–6:00 pm Registration, Check-In
6:00–7:00 pm Networking and Dinner
7:00–8:30 pm Speaker Presentation and Q/A Session
Location:
Abbvie Inc.
One North Waukegan Road
Building AP30 LL, Conference Room E
North Chicago, IL 60064-6220
Find directions online or call +1 800 255 5162
Registration Fee:
RAPS Members: $40 Nonmembers: $50
(Prior to 12 August)
Registration Fee:
RAPS Members: $50 Nonmembers: $60
(On or after 12 August)
Speakers:
Eric Floyd, PhD, MBA, MS, chief science officer and president, compliance services, Dohmen Life Science Services
Terry J. Dagnon, MS, senior vice president, operations, Dohmen Life Science Services
Local Contact:
Carol Cooper, RAC, RAPS Chicago Chapter Chair
RAPS Contact:
Wesley Carr, +1 301 770 2920
Eric Floyd is an expert in US and global regulatory affairs and clinical development. Floyd serves as the president of compliance services and chief scientific officer for Dohmen Life Science Services. He leads Dohmen's growing regulatory consulting practice as well as a portfolio of pre-commercial and postapproval outsourced services in quality, regulatory, pharmacovigilance, REMS, medical affairs and medical communications. Floyd brings decades of experience leading global regulatory affairs and quality assurance divisions within Novartis, Cephalon, Hospira and, most recently, Lundbeck; as well as in-depth knowledge of the US Food and Drug Administration and navigating regulatory bodies worldwide.
Floyd's experience with global regulators in pharma, biologics, and in particular within the orphan drug space helps clients navigate new paradigms for development, clinical trial and ongoing safety requirements.
With an MS in neuroscience, MBA in pharmaceutical marketing and PhD in neurophysiology, Floyd joined Dohmen after serving as vice president of US regulatory affairs and clinical quality assurance and vice president of global regulatory affairs at Lundbeck Inc. Prior to his time at Lundbeck, he was vice president of worldwide regulatory affairs at Cephalon Inc. and was vice president and global head of respiratory, dermatology and tropical medicines drug regulatory affairs at Novartis. Floyd has also worked in global regulatory affairs at Aventis Pharmaceuticals, Bristol-Myers Squibb Co. and Merck Research Laboratories
Dagnon’s 20 years of regulatory experience has involved responsibility from research to postmarket with a large number of domestic and global investigational and marketing approvals in the pharmaceutical and medical device industries. Dagnon is also experienced in quality and compliance and working with R&D, marketing, sales, legal, manufacturing, quality and supply chain organizations.
Dagnon began his career in the pharmaceutical industry as the regulatory affairs manager for Physician Reliance Network Inc. (now known as US Oncology). He continued his regulatory affairs career at Johnson & Johnson Medical Inc. with global regulatory responsibility for the wound care, skin care and tissue engineering franchises. He then served as the North America head of regulatory affairs at Alcon a Novartis company prior to joining DLSS in March 2014.
Dagnon is currently the senior vice president of operations for Dohmen Life Science Services and is responsible for all operational activities at the Denver site and in running the following service lines servicing pharmaceutical, biologics, medtech and rare industry segments: QA, RA, safety, medical affairs, CMC, project management consulting and quality management system outsourcing.