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.