Working together to achieve shared goals in product packaging and labeling

Transcription

1 Working together to achieve shared goals in product packaging and labeling Following on from our 10th anniversary edition Pharma Packaging and Labeling will be returning to Philadelphia for its 11th edition. Covering all key aspects of the packaging and labeling value chain, Pharma Packaging and Labeling East Coast will deliver key, actionable insight on the very latest regulatory requirements, technological innovations, and strategic developments, and how to implement them into your packaging and labeling chain with both maximum efficiency and minimal cost. From addressing the evolving regulations, to exploring the potential of disruptive technologies such as Artificial Intelligence and Block Chain, and considering best practices for brand alignment and anticounterfeiting, this year s events core theme is end-to-end collaboration to improve the efficiency of your supply chain. Confirmed Speakers Debra McNaughton, Executive Director, Global Labeling Management, Pfizer Gerrit-Jan Nijveldt, Senior Director, Global Labeling, Sanofi Shawn Ellerman, Assistant Special Agent in Charge, US Drug Enforcement Administration Sriman Banerjee, Head Packaging Development Global Respiratory Category, GlaxoSmithKline Christine Vidsens, Associate Director, Regulatory Affairs, Merck Jennifer Vandiver, Associate Director, Alkermes Bryan Morris, Sr. Manager, Global Business Process Owner, Artwork, Biogen Ann Baffoe-Bonnie, Regulatory Affairs Manager, Bausch Health Christina Fang, Director, Global Regulatory Lead, Amgen Mary Zhang, CBP National Account Manager, US Customs & Borders Protection Harold Hunt, Director, CMC & Supply Chain, Trevena Nicole Quallis, Labeling Manager, Bausch Health Carl Accettura, Vice President, PharmoRx Therapeutics Mark Willis, Global Director, Corporate Social Responsibility, Fresenius Medical Care Christopher Smith, Director, Federal Public Policy, National Association of Chain Drug Stores Brian Files, Government Affairs, Strategic Policy Executive, Drug Supply Chain Security Act (DSCSA) Gerald Klein, Chief Medical Officer, EtecRx

2 Day One Wednesday 20 th February :15 Registration and refreshments 08:50 09:00 09:30 Chair s opening remarks OPENING KEYNOTE: The future state of end-to-end labeling What is end-to-end labeling (short reminder) The use of content authoring Metadata in labeling (SPL and IDMP) Automated tracking AI in Labeling or labeling far far away.(or not) future Gerrit-Jan Nijveldt, Senior Director, Global Labeling, Sanofi Blue Software Progressing your journey through to a fully digitalized labeling strategy Using electronic labeling to optimize patient engagement Gain an insight into QR codes and how this can improve your labeling strategy 10:00 Understanding the benefits of innovative labeling solutions with NFC technology Identifying the opportunities in digitally printed labeling and how this can add value, adhere to regulations and boost brand impact Sriman Banerjee, Head Packaging Development Global Respiratory Category, GlaxoSmithKline 10:30 Morning refreshments and networking 11:00 11:30 12:00 Inspection preparedness: surviving and thriving! Tried and tested end-to-end labelling in the new era Meeting patients needs whilst maintaining compliance Debra McNaughton, Executive Director, Global Labeling Management, Pfizer Perigord PACKAGING AND LABELING PANEL: A perfect marriage! How to work in harmony Ensuring best results through a strong relationship between packaging and labeling Allowing flexibility in your processes to reduce delays and meet guidelines Ensuring strong communication between both parties through advanced communication tools to reduce unexpected delays Implementing seamless integration using software to ensure smooth working between both parties Christine Vidsens, Associate Director, Regulatory Affairs, Merck Nicole Quallis, Labeling Manager, Bausch Health Christina Fang, Director, Global Regulatory Lead, Amgen

3 12:30 TECH SPOTLIGHT: Sacmi Imola 12:45 Lunch and networking 13:45 14:15 14:45 15:15 Regulatory update Keeping up-to-date with US Customs and Border Protection (CBP), importation Centers of Excellence and Expertise General marking requirements for CBP Partnership programs Mary Zhang, CBP National Account Manager, US Customs & Borders Protection Intagras Developing packaging and labeling for usability and reduction of medication errors Incorporating regulatory, quality, and commercial requirements into container closure selection/development Development of blister packaging and labeling for child resistance, usability and functionality Development of packaging and labeling for differentiation and correct storage Jennifer Vandiver, Associate Director, Alkermes Global Vision 15:45 Afternoon refreshments and networking INTERACTIVE ROUNDTABLE DISCUSSIONS 16:15 Facilitated by industry experts, this is your chance to discuss key topics and challenges in smaller, interactive groups. You will be able to share your own experiences and hear from others; benchmark; exchange ideas and get clear answers to specific questions RT1 RT2 RT3 RT4 Blockchain: harnessing blockchains power to improve track and trace Label and artwork management systems: exploring new concepts Global update on the DSCSA Brian Files, Government Affairs, Strategic Policy Executive, Drug Supply Chain Security Act (DSCSA) Building a defence: Protecting your brand through global anti-counterfeiting

4 17:15 Chair s summary and close of conference Day Two Thursday 21 st February :15 Registration and refreshments 08:50 09: Chair s opening remarks Understanding the big picture: what serialization means to your business The different phases in serialization maturity and how this will impact your supply chain Roadmap to full implementation and aggregation Understanding how serialization can benefit the pharmaceutical manufacturer through tighter regulations to reduce counterfeit drugs Adapting to change: ensuring a flexible artwork process to meet new requirements Mark Willis, Global Director, Corporate Social Responsibility, Fresenius Medical Care Loftware FDA s Q&A guidance on serialization Dispensers needing 2D and linear barcodes on products Problems with space on small packages and the use of barcodes 10:00 Placement of human readable codes on packages Smallest saleable unit and dispensing units and barcodes Christopher Smith, Director, Federal Public Policy, National Association of Chain Drug Stores 10:30 Amplexor Life Sciences 11:00 Morning refreshments and networking 11:30 12:30 AGENDA HIGHLIGHT Fighting fakes: advancing the three pillars of the National Drug Control Strategy Ensuring a comprehensive analysis of risks and countermeasures to tackle counterfeit drugs Protecting your brand through global anti-counterfeiting and brand safety awareness Highlighting DEA s efforts to reduce abuse nationwide Raising public awareness through the DEA and pharma industry Shawn Ellerman, Assistant Special Agent in Charge, US Drug Enforcement Administration Right the First Time: improving efficiency while maintaining compliance Using the FDA prescribed framework for quality assurance Managing metrics through more lean processes

5 Embedding a culture of continuous improvement for manufacturing Providing a broad framework to plan, design and implement a successful labeling and packaging strategy Bryan Morris, Sr. Manager, Global Business Process Owner, Artwork, Biogen 13:00 Lunch and networking HANDS ON! CMO challenges with current regulations and serialization Highlighting the problems with anti-counterfeit solutions while having different manufacturers and therefore losing corporate identity Adhering to current regulations across multiple pharma company lines while 14:00 ensuring company guidelines are adhered to Planning for next serialization aggregation systems in the US Understanding the costs for implementation and the impact this will have to your business Carl Accettura, Vice President, PharmoRx Therapeutics REFLECTION ZONE: If you re just starting up or an expert in this field, there is a roundtable for you! Choose from one of the following roundtables to suit your needs: 14:30 1. Sustainability: innovative ideas in packaging materials 2. Artificial intelligence and block chain 3. Serialization and where are we now? Ann Baffoe-Bonnie, Regulatory Affairs Manager, Bausch Health 4. Building a robust supply chain Harold Hunt, Director, CMC & Supply Chain, Trevena 15:30 Chair s summary and close of conference