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Pharma Packaging and Labeling USA 2016 - Conference Program Day 1 @ArenaIntPharma

North America, USA, Health, Pharmaceuticals, OTC (Over the Counter) Drugs, DIY, Consumer Durables, Primary Packaging, Caps, Lids, Easy-Open Closures, Pharmaceutical Components, Blister Packs, Secondary Packaging, Labels, Machinery, Packaging Decoration, Colouring, Labelling, Sleeving, Supply Chain Services, Product Development Services, Design, Brand Design, Branding

The conference programme is now complete. If you are interested in contributing a case study, please get in touch with the programme manager:

Kathryn Essery
Email: Kathryn.Essery@arena-international.com
Telephone: +44 207 936 6486

Day 1, Wed, Feb 24th

07:30 - 08:15 Registration and refreshments

08:15 - 08:30 Chair’s opening remarks
Chair Su-Yueh Lin – Sr. Director, Head of Regulatory Labeling - REGENERON PHARMACEUTICALS, INC.

08:30 - 09:00 Case Study: Structured content management for labeling – exploring lessons learned and opportunities
Speaker Carolyn Roderick – Director, Regulatory Labeling - AMGEN

  • Developing the vision
  • Understanding labeling content and opportunities
  • Labeling proof of concept
  • Future for SCM in labeling and beyond

09:00 - 09:30 Patient labeling for prescription products – room for improvement
Speaker Amy Ebel – Director, Global Regulatory Affairs, Labeling - GSK

  • Providing an overview of patient labeling regulations
  • Exploring differences between company sponsored patient labeling and consumer medication information (CMI)
  • Identifying current problems with patient labeling
  • Tips and tricks for improved patient labeling
  • Current trends in patient labeling and ongoing FDA activities concerning patient labeling

09:30 - 10:00 Realizing your branding potential – keeping ahead of the curve for your future customer pool to ensure longevity in the market
Speaker Guido Schmitz – Director, Packaging Design - BAYER

  • Establishing your need for branding and the effect it can have on your company
  • Looking beyond regulatory to explore the marketing potential in your labeling and the product as a whole
  • Defining the need to think for the future and your next generation of patients to ensure you stay on top of market expectations and needs
  • Exploring branding solutions for the future through identifying who your future market are now and determining their marketing expectations
  • Utilizing your branding for present and for the future - incorporating an effective branding strategy in to your business model and strategy

10:00 - 10:30 Morning refreshments and networking

10:30 - 11:00 The importance of gaining commercial input in device & packaging development
Speaker Julia Zakhari – Associate Director, Marketing - SANOFI

  • How commercial insights can help inform packaging and device decisions early-on - assessing implications of the competitive landscape and patient/end-user considerations
  • Determining how best to involve the commercial team in CMC & Regulatory activities related to packaging and device
  • Exploring packaging best practices from the consumer packaged goods industry

11:00 - 11:30 Collaborating with packaging suppliers to enhance the consumer experience in the OTC space
Speaker Amir Perlmutter – Senior Technical Director, Packaging - FORMERLY OF NOVARTIS

  • Discussing open innovation for OTC products
  • Covering the process to obtain consumer relevant and meaningful packaging innovation
  • Deliberating the close interaction between technology providers and target consumers to ensure a positive consumer experience

11:30 - 12:00 New Solutions for Healthcare Packaging – Presenting and demonstrating innovation and new tools for:
Speaker Craig Curran – VP Sales and Marketing - Nosco, Inc.

  • Color Management
  • Pre-Serialized Labels and Cartons with Data Management
  • Blister Constructions for OTC
  • Combination Cartons and Inserts
  • Vision Inspection for Color as well as Static and Variable Data
  • Personalized Packaging

12:00 - 13:30 Lunch and networking

13:30 - 14:15 Panel Discussion: Reaching peak efficiency in your packaging and labeling departments – promoting effective project management
Speaker Michael Daly – Director, Supply Chain - VALEANT PHARMACEUTICALS
Speaker Ann C. Schaefer – Associate Director, Supply Chain Management - ACORDA THERAPEUTICS INC.

  • Determining your role within a wider chain to distinguish the effect you have on others’ timelines
  • Establishing efficiency savings gained through effective project management
  • Highlighting gains to be made through appointing project leader to ensure timelines are met and sync with others’
  • Promoting effective communication between departments to maximise your efficiency and realise external timelines
  • Discussing the future for project management across packaging and labeling to determine how you could cut your time and costs

14:15 - 14:45 Exploring the advent of mobile apps – from the impact on your labeling to navigating the FDA
Speaker Thomas Conroy, RPh., J.D. – Director, Global Regulatory Affairs, Promotion Compliance - OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

  • Establishing current trends for mobile health care
  • Discussing the evolution in labeling in line with the move online
  • Analyzing FDA standards for patient information when utilizing mobile technology for your labeling
  • Navigating emerging technologies to keep ahead of your competition while ensuring you deliver exceptional standard of care to customers

14:45 - 15:15 New Rx product launches
Speaker Carl J. Accettura – Vice President and General Manager - PHARMORX THERAPEUTICS INC.

  • Critical management of packaging, labeling, and supply chain preparations for Pharma Rx product launches
  • Case study of Specialty Pharmacy and Specialty Distribution Rx product launch with FDA REMS and DEA compliance considerations
  • Commercial strategy considerations and the physician-patient benefits of end to end tracking
  • Appreciating more than the known end to end benefits to ensure product security - what more can you deliver?
  • Opportunities beyond the regulatory compliance system to determine commercialization and launch benefits from end to end tracking

15:15 - 15:45 Discussing compliance life cycle management and total cost of ownership
Speaker Erik Bronander – Senior Director Sales, Americas - Adents

  • Addressing compliance systems implemented to meet regulatory or supply chain network compliance requirements in labeling and data exchange for packaged products from manufacturers
  • Appreciating the overall cost of the system throughout its lifecycle as well as ensuring cost control during program implementation phase
  • Highlighting the how’s and why’s of TCO and what you should know about compliance

15:45 - 16:15 Afternoon refreshments and networking

16:15 - 16:45 How to Amazon-proof your pharmaceutical business using serialization and digital transformation
Speaker Raj Subramanyam – Senior Manager, Global Serialization Technology Program - CSL BEHRING LLC

  • Understanding the new digital environment, and where your business will encounter major threats
  • Exploring what other businesses are doing to mitigate such threats
  • Extrapolating what you can do
  • Identifying how serialization and digital transformation can help

16:45 - 17:15 Moving beyond your role in serialization – how your efforts are appreciated further down the line
Speaker Eugene J. Hackett – Director, Corporate Security - BRISTOL-MYERS SQUIBB

  • Exploring supply chain best practice to highlight their role in anti-counterfeiting
  • Establishing supply chain security pre-serialization and the improvements seen so far
  • Determining the role serialization has further down the supply chain to ensure product security in shipment
  • Communicating difficulties in drug protection in supply chain security to establish where packaging and labeling could go next
  • Looking to the future to establish effective partnerships down the supply chain to ensure the security of your products

17:15 - 17:45 Application of raman technology in detection and authentication of fake medicine
Speaker Anna Luczak – Scientist - BRISTOL-MYERS SQUIBB

  • Assessing the scope of the problem and currently available portable and benchtop Raman techniques for counterfeit detection
  • "Good, bad, and ugly" counterfeit medicine and the role of Raman technology in detecting them
  • Delivering pros and cons for using Raman spectrometers in counterfeit drug detection
  • Raman spectrometers as a screening devices preventing fake medicine entering the US market
  • Highlighting the importance of having Raman technology and exploring trends in fake medicine at various dispensing points within the supply chain
  • Looking to the future of pharmaceutical counterfeit medicine in biologics and how to detect them

17:45 - 18:00 Chair’s closing remarks and end of Day 1
Chair Su-Yueh Lin – Sr. Director, Head of Regulatory Labeling - REGENERON PHARMACEUTICALS, INC.

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