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- Overcoming the challenges in labeling - examining the viability of paperless systems and methods to optimize your labeling function
- CASE STUDY: Overcoming the problem of growing inset sizes for pharma - outlining the paperless-labeling pilots of PhRMA to date and examining the results
- Examining the key considerations for implementation of paperless systems
- Assessing the hurdles and drawbacks of a paperless labeling initiative
- Evaluating what remaining content would necessitate inclusion in printed materials to assess the extent of a solution electronic labeling offers
- Clarifying the efforts taken to mitigate risks and the possibility of adverse implications
- Understanding the impact on industry of a successful transition to paperless systems
- Outlining the next steps in achieving PhRMA’s aims and objectives
- Mark Paxton, Associate Vice President, PhRMA
- Evaluating the creation and use of core data sheets as a tool to increase efficiency and aid change control in labeling and across the company
- Understanding the scope of utility of a core data sheet across different departments
- Outlining the proper content and key considerations for information inclusion
- Establishing the optimal methods of drafting, creating and updating core data sheets
- Reviewing the benefits, drawbacks and limitations of core data sheets
- Gerrit-Jan Nijveldt, Senior Director Regulatory Labeling, SAN OFIAVENTIS
- CASE STUDY: Achieving operational improvements to in-house label collaboration and correction systems to improve time efficiency and aid efficient change-control
- Analyzing events that can drive the creation of a new system
- Exploring how FDA changes affect the creation of this system
- Eliminating redundancies through creation of a detailed system to archive and track labels
- Understanding the impact of the created system on international products
- Outlining the impact on current systems after acquisition/merger
- Uncovering effect of in-house improvements to the current system on in-house teams
- Forecasting the impact of future technologies on streamlining the process
- Terrance Carr, Writer and Editor
- PANEL DISCUSSION: Assessing the optimal outcome for patients, physicians and the pharmaceutical industry through evaluation of electronic and paperless labeling as an alternative information service
- Realistically evaluating the viability of a paperless labeling program
- Evaluating the pros and cons for patients, prescribers and pharmacies of paper based vs. paperless systems
- Clarifying the current regulatory environment and the expected next steps for its direction
- Outlining the progress of electronic labeling initiatives overseas and assessing what could be learned from the steps forward Abroad
- Examining the interaction of industry and the FDA to assess the degree of FDA understanding of industry concerns
- Understanding the points of conflict between the FDA and industry and overcoming the main agency objections
- Outlining the essential building blocks of a move towards electronic labeling
- Exploring the anticipated timelines for implementation and the expected structure of any roll-out
- Understanding the major impediments to rapid implementation of an electronic labeling system and assessing options to overcome these obstacles
- Establishing the next steps on the way to achieving a paperless system
- Richard J. Scholz, RPh., Esquire, Jacobs Scholz & Associates, representing the PHARMACEUTICAL PRINTED LITERATURE ASS OCIATI ON
- Mark Paxton, Associate Vice President, Pharma
- Virginia Hogan, Associate Director RA Labeling, TEVA PHARMACEUTICALS
- Bill Bosley, Sr. Labeling Specialist, Proprietary Affairs Labeling, WATS ON PHARMACEUTICALS Lonnie Smith, Project Manager, SPL , U.S. FOOD AND DRUG ADMINISTRATI ON (FDA )
- Uncovering the next steps in moves towards product security through anti-counterfeiting, serialization and e-pedigree efforts; examining practical, industry-wide considerations
- CASE STUDY: Exploring the implementation and results of an anti-counterfeiting system
- Outlining the key considerations when developing a fit-for purpose anti-counterfeiting strategy
- Understanding the technologies in use and the factors influencing the choice of these technologies
- Clarifying the process and operation of a new anti-counterfeiting Investment
- Assessing the authentication functionality of the labeling choices
- Achieving ongoing protection of product lines into the future, and the major priorities for further investment
- Scott Kammer, Global Product Security, TA KEDA PHARMACEUTICALS
- CASE STUDY: Outlining the fundamentals and overcoming the hurdles of an affordable and fit-for purpose serialization scheme
- Identifying the specific aims and objectives of the serialization project
- Understanding the key considerations for harmonizing with international systems
- Clarifying the major points of difference and considerations when working with in-house vs CMO partners
- Outlining the roles and challenges of different departments collaborating on the project
- Explaining the rationale for choices made in design and implementation of the system
- Selecting and implementing the correct software and hardware Systems
- Lessons learned from collaboration, planning and implementation
- Examining and monitoring the system to ensure continued quality and compliance
- Reviewing the major successes and challenges of the project, its functionality, cost effectiveness and potential improvements
- Kim Riley, PhD, Program Manager, Global P&L, SHIRE
- Encouraging a full understanding of counterfeiting and diversion problems and outlining the most effective measures to counter these threats
- Outlining dangers and the key steps in preventing counterfeiting and diversion
- Raising the profile of a complete anti-counterfeiting system by assessing and presenting the realistic dangers of ignoring the extent of the threat
- Maximizing product security when moving into new and more “threatening” environments - assessing the global problem areas
- Exploring the newest technologies in anti-counterfeiting security features and their potential
- Assessing the extent to which serialization and e-pedigree may tie with and/or enhance you product security
- Patrick Lukulay, Director, promoting the quality of medicines (PQM) program, us. PHARMACOPEIA
- Building a global view of pharmaceutical serialization to achieve global system harmonization
- Understanding the implications in pharmaceutical packaging, labeling and supply chain of an un-harmonized serialization system
- Uncovering the parameters of the project and the constraints and boundaries within which the system must be developed
- Outlining the dynamics of the harmonization effort to better understand the priorities of main stakeholders and their roles in development
- Establishing the status of the harmonization effort and the key steps in progress being made
- Clarifying the ideal end-point for global serialization protocols; outlining the main hurdles to achieving this optimal outcome
- Analyzing the extent to which a harmonized serialization standard will work with or against e-pedigree in a global system
- Forecasting the realistic standard protocols to be expected - establishing where and why the line will be drawn
- Bob Celeste, Director, GS1 HEALTHCARE US
- Panel discussion: resolving the major sticking points in creating a coherent e-pedigree system, suitable for industry-wide use
- Reviewing the essential considerations for big and small pharma , biotech and generics manufacturers in design of industry standards
- Proposing solutions to overcome the diverse demands of stakeholders
- Generating progress towards implementable guidelines and practical standards
- Assessing the available technological solutions for viability as an industry-wide implementation ? Continually encouraging preparedness for implementation through adoption of fl exible systems and considered resource allocation
- Mitchell Goldberg, vice-president, sales and marketing, sigmapharm laboratories
- Bob Celeste, director, GS1 HEALTHCARE US
- Kim riley, phd., program manager, global p&l, shire
- Examining the Current Challenges in pharmaceutical packaging to ensure Optimal performance for all stakeholders
- Exploiting web based serialization ready labeling to combat counterfeiting within medical and pharmaceutical supplies
- Exploring the key issues in keeping your products safe from counterfeiting
- Understanding the creation of unique serialization codes for individual products during the production process
- Managing secure high speed printing and verification of these codes
- Having complete confidence in the subsequent efficient storage and retrieval of any of these millions of codes at any point within the lifecycle of a product and beyond.
- Dave Taylor, product manager, life sciences, PRISYM ID
- Updating the regulatory requirements for packaging validation and cold chain shipping
- Outlining the expectations for ideal validation of pharmaceutical packaging
- Understanding the “philosophical standpoint” of the FDA in its demands on quality packaging and shipping systems - where responsibility lies
- Enhancing the compliance of your supply chain with clear expectations of players at each stage - manufacturer, distributor, pharmacy and patient
- Evaluating fit-for-purpose solutions to ensure efficient and compliant packaging that maintains product quality
- Suzan R. Lanz, Associate Director, Project Management, SAVIENT PHARMACEUTICALS
- Optimizing your labeling through a full understanding of changing content and operation requirements
- Optimizing patient compliance and patient safety with a full understanding of non-compliance implications and promising packaging and labeling improvements
- Establishing the dangers of non-compliance for the patient and beyond to best understand the need for advances in packaging and labeling
- Clarifying the global regulatory landscape for pharmaceutical packaging for patient protection
- Outlining the major considerations for patient compliance when packaging for global distribution
- Optimizing patient compliance through intelligent packaging innovation
- Overcoming the hurdles to implementing a packaging overhaul for established products
- Walter Berghahn, Executive Director, HEALTH CARE COMPLIAN CE PA CKAGING COUNCIL
- Understanding the upcoming labeling regulations and how they will affect your labeling role; conversion from CMI to PMI
- Outlining the advantages of a sponsor-controlled PMI label
- Identifying the mechanisms necessary for successful implementation of PMI
- Assessing the potential impact of this replacement for all players from industry-regulatory-pharmacy-patient
- Successfully meeting the future challenges in changes to FDA and pharma labeling remits and responsibilities
- Bill Bosley, Sr. Labeling Specialist, Proprietary Affairs Labeling, WATSON PHARMACEUTICALS
- Exploring the relationship between product labeling and promotion to best prepare compliant marketing materials to meet DDMAC requirements
- Outlining the basics of post-approval product promotion - clarifying what aspects of products are marketable in the US
- Optimizing market impact whilst mitigating risks of lengthy review and amendment processes
- Determining the key lessons from feedback received from DDMAC and the trends in regulatory allowance/acceptability
- Clarifying the way DDMAC views different sections of product labels and the rationale for allowing clinical effects and results to be promotable or otherwise
- Evaluating the extent to which statements from specific labeling sections are prohibited for promotion
- Reviewing the changes in acceptable marketing material over recent years and how to maximize impact within the current enforcement framework
- Dr. Alicia Tatro, Associate Director, Regulatory Affairs, Labeling, STIEFEL LABORAT ORIES
- Examining the implementation of PIM in Europe to successfully prepare for system and procedure compliance
- Understanding the current state-of-play with an update on the European stage of implementation
- Outlining the hurdles and obstacles experienced so far and the knock-on effects for implementation timelines
- Reviewing the feedback on the initial stages of PIM operations and the affect of these trials on the expected timelines for roll-out
- Experience to date in PIM pilot
- Barbara Wolfe, Senior Labeling Manager, Global Labeling Operations, Worldwide Safety and Regulatory Operations, PFIZER
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