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 2, Thu, Feb 25th

08:15 - 08:45 Registration and refreshments

08:45 - 09:00 Chair’s opening remarks
Chair Su-Yueh Lin – Sr. Director, Head of Regulatory Labeling - REGENERON PHARMACEUTICALS, INC.

09:00 - 09:30 FDA’s risk based strategy for imports
Speaker Ted Poplawski – Special Assistant to the Director - FDA, DIVISION OF IMPORT OPERATIONS

• Assessing differing international regulations to determine potential areas and reduce likelihood of a long hold up
• Acknowledging the serialization needs and how this will affect your drugs’ customs experience
• Determining your strategy if the worst case scenario happens - how well prepared are you for a customs hold up?
• Exploring the new IMPD changes to determine the effect on your customs relations
• Pinpointing areas for caution to establish future caution and ensure preparedness

09:30 - 10:00 Discussing the Centers of Excellence and Expertise – trade in the 21st Century and the impact on your global distribution
Speaker Anthony Orosz – Assistant Director, CBP’s Pharmaceutical Center of Excellence and Expertise - US CUSTOMS AND BORDER PROTECTION

• Establishing motivations for CBP Centers to increase uniformity of practices across ports of entry, facilitating timely resolution of trade compliance issues nationwide
• Delivering the goals of the Center and it’s achievements to date
• Exploring recent expansion of the Centers to include processing for the entire industry
• Delivering key strategies for ensuring your drugs make it through customs

10:00 - 10:30 Exploring the proofreading process – tips, tricks and ROI case studies
Speaker Peter Muller – Managing Director, Americas - Schlafender Hase Inc.

• Deciphering the true cost of manually proofreading labeling components – a return on investment case study for proofreading software
• Interpreting what really happens when converting Word to PDF
• Understanding why there are mistakes in your PDF artwork
• Avoiding font issues

10:30 - 11:00 Morning refreshments and networking

11:00 - 11:30 Handling local regulations with your Core Data Sheet to avoid over-complications
Speaker Roya Behbahani – Global Labeling Cluster Head - Pfizer

• Determining the most effective use of your CDS as a baseline to ensure ease of use internationally
• Assessing what needs to go in your CDS as an absolute base level when different countries have different regulations
• Discussing challenges which arise with a cluttered CDS to promote a streamlined presence and maximize international compliance
• Evaluating when regulations changes should lead to a change in your CDS to ensure ease of use internationally
• Exploring the future of your CDS to ensure everyone can get the most out of it

11:30 - 12:00 The challenges and benefits of bringing your established or acquired products Core Data Sheet to up to current corporate standards
Speaker Debra McNaughton – Head, Global Labeling Management, Worldwide Safety & Regulatory - PFIZER

• Assessing the quality of CDS for established or acquired products against current standards
• Evaluating the greatest risks and benefits and communicating this effectively to the organization top
• Selection, prioritization and the budget necessary for upgrading your CDS
• Awareness of impacts, both internally and externally

12:00 - 13:00 Lunch and networking

13:00 - 13:30 Management of end to end labeling process – from corporate to label development
Speaker Gerrit-Jan Nijveldt – Associate Director, Regulatory Labeling - SANOFI

• Exploring the reasons for tracking – deliberating benefits and bets practice
• What is meant with end to end labeling and how can this improve your labeling?
• Deciphering the complexities with tracking – what are the main challenges and how do you overcome these?

13:30 - 14:00 Afternoon refreshments and networking

14:00 - 15:30 Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables

• Answering the eternal question - how to minimize timelines and delays in your artwork? Patricia Petruska – Speaker
• Assessing your approach to EPI to determine the further opportunities you can utilize Michael Trocchia – Speaker
• Deciphering your customs and border challenges to prevent costly delays Anthony Orosz – Speaker
• Discussing your role in patient experience and adherence – what more could and should we be doing? Jennifer Nixon Sekawungu – Speaker
• Overview of end to end labeling and implementation Michelle L. Halliez – Speaker

15:30 - 15:45 Chair’s closing remarks and close of conference
Chair Su-Yueh Lin – Sr. Director, Head of Regulatory Labeling - REGENERON PHARMACEUTICALS, INC.