E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs) . The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.
*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job.
ISPE Releases New Guidance for Standardizing Use of Booklet Labels in Global Clinical Trials
ISPE issued the industry’s first-ever guidance to help companies conducting clinical trials in multiple countries standardize their use of booklet labels. The Guide provides templates, guidelines, and tools to make it easier for companies to use booklet labels consistently and effectively and justify their booklet label methods to international regulatory authorities. More.
ISPE Releases New Guidance for Definition and Use of Non-Investigational Medicinal Products in
ISPE has issued groundbreaking guidance to help companies involved in clinical trials determine which medications qualify as non-investigational medicinal products (or NIMPs). The document also contains practical strategies for risk management as it relates to classifying, sourcing, and packaging NIMPs. More.
ISPE Conference June 2013 to Feature Clinical Supply Chain Track
The ISPE Conference, “World-Class Supply – End to End,” to be held 13-14 June in Prague, Czech Republic, will feature a Clinical Supply Chain track with significant content on the GMP/GCP interface. The conference will also include presentations by two MHRA regulators, a keynote from Accenture, and an exciting and unique networking dinner event at a local venue in Prague. More.
What’s on the Horizon for the IP Community in 2013
The IP COP gives an update on accomplishments in 2012 and new activities and events being planned for 2013. More. ( 109 KB)
ISPE Clinical Trial Materials Training Course
The ISPE Training Course, “Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes,” will take place in May in Brussels, Belgium, in September in Burlingame, California, USA, and in December in Tampa, Florida, USA. More.
Save the Date! ISPE 2013 Annual Meeting
Mark your calendars for the ISPE 2013 Annual Meeting 3 – 6 November in our national capital, Washington, DC, USA. The IP COP education track will be very interesting and informative:
Title: Defining the New Landscape of Clinical Supplies
Keep an eye out on the ISPE website as more details unfold!
Newly Revised COP Operations Handbook Now Available
The Community of Practice (COP) Operations Handbook has been recently revised to provide guidance on governance, organizational structure, and operational procedures for COPs. The Operations Handbook is intended to serve as a resource for COP Steering Committee Members and local COP leaders, as well as all Volunteer groups or individuals who interact with ISPE COPs. Visit the Volunteer Resources section of the ISPE website to download a copy of the newly revised COP Operations Handbook.
Survey Results Confirm Need for Guidance on Non Investigational Medicinal Products
Results of a survey on how the pharmaceutical industry manages Non Investigational Medicinal Products or NIMPs (materials considered outside the scope of the regulatory filing requirements for Investigational Medicinal Products or IMPs) are available in the September/October 2012 issue of Pharmaceutical Engineering. Data from the survey, conducted by ISPE’s Investigational Products community, confirms the need for ISPE guidance for such materials to supplement the EMA document on requirements for clinical trial dossiers containing NIMPs. More.
Publish Your Article in Pharmaceutical Engineering
Pharmaceutical Engineering is seeking articles for the May/June 2013 issue. Currently, they are seeking a cover story or lead article on Clinical Manufacturing, which could include: technology transfer, regulatory implications (PQLI), scale-up, process verification, impact on Process Performance Qualification (PPQ), selection of a CMO, and comparator studies.
They are also looking for special features and guest editorials on new technology, contemporary quality management practices, and production innovation. Topics could include: engineering and design; product development; commercial manufacturing; quality and compliance; and product lifecycle management.
The deadline to submit is 2 January 2013. For more information, please visit www.PharmaceuticalEngineering.org and click on the "Submit Article" tab. If you have any questions or would like to recommend a complementary topic for this issue, please email: firstname.lastname@example.org.
Message from the IP COP North America Steering Committee
The Investigational Products Community of Practice (IP COP) Steering Committee explains why it is extremely excited about the topics and speakers lined up for the 2012 ISPE Annual Meeting. More.
IP COP’s Annual European Conference Set for 24-25 October in Berlin
The ISPE IP COP is pleased to announce that their annual European Conference will take place 24-25 October 2012 in Berlin, Germany. Current hot topics from the industry will be addressed including views of regulators in an optimal mix of presentations, case studies, and workshops. A few examples include: working with Eastern Europe and China; approaches to pooling medication; and practical feedback from sites and patients. Multiple networking opportunities will also be available, including with key opinion leaders and regulators.
Come join the IP COP in Berlin for two days fully dedicated to sharing experiences and learning best practices in the clinical supply arena! More.
Message from the IP COP North America and Europe Steering Committee Chairs
Steve Yoder, Chair of the IP COP North America Steering Committee, and Esther Sadler-Williams, Chair of the IP COP Europe Steering Committee, provide a progress update on several key objectives of this global IP community. More.
IP COP Seeking New Steering Committee Members
Both IP COP North America and IP COP Europe are recruiting volunteers to serve as Steering Committee Members. The incumbent is typically a Subject Matter Expert in the discipline of the COP and is a major contributor to the overall strategy the COP will use in approaching technical issues and work streams.
IP COP LinkedIn Group
The IP-COP Linked-In discussion group established at the start of the year is now up to 312 members strong and growing rapidly. The group will feature timely discussions on current topics of interest within the clinical supplies space and will also provide useful links to pertinent ISPE materials. It is hoped that you will find this a great place to connect with others and that you will also find that the discussions contribute to your understanding of the issues we all face in delivering lifesaving treatments to our patients. Please feel free to read, contribute to a topic already being discussed, or start your own discussion. To join, click on the link, http://www.linkedin.com/groups?home=&gid=4231057&trk=anet_ug_hm, then click on the yellow box to join the group and follow the prompts. For more information, contact Gayle Flynn: email@example.com. The IP COP looks forward to seeing you on the boards!
Use of Booklet Labels on Investigational Medicinal Products (IMPs)
A concept paper by the ISPE COP Booklet Label Task Team reflects on results of a study site survey, draws conclusions from an assessment on comparison of Booklet Labels versus Single Panel Labels performed, discusses benefits of a Good Practice Guide, and defines the need for training on the proper use of booklet labels. More.
IP COP’s Annual European Conference Set for 24-25 October in Berlin
The ISPE IP COP is pleased to announce that their annual European Conference will take place 24-25 October 2012 in Berlin, Germany. Current hot topics from the industry will be addressed including views of regulators in an optimal mix of presentations, case studies, and workshops. A few examples include: working with Eastern Europe and China; approaches to pooling medication; and practical feedback from sites and patients. Multiple networking opportunities will also be available, including with key opinion leaders and regulators. Come join the IP COP in Berlin for two days fully dedicated to sharing experiences and learning best practices in the clinical supply arena! More.
Ground-Breaking Guide Paves Way for Industry Standard on Interactive Response Technology
Interactive Response Technology (IRT) has been used in the pharmaceutical industry for more than 15 years and is becoming a more widespread application to support various clinical trial activities. Yet, there is currently no industry standard on implementing IRT. In an effort to address the need for guidance on how to use, design and validate, and monitor the use and effectiveness of this technology, ISPE published its first-ever Good Practice Guide on Interactive Response Technology. The Guide establishes minimal functional standards for these systems. More.
ISPE Releases First-Ever Industry Resource for Comparator Processes
ISPE released in March 2012 the ISPE Good Practice Guide: Comparator Management. The pharmaceutical industry’s first-ever resource for comparator processes, the Guide provides the industry with a complete picture of the steps to be followed to execute a clinical study that includes comparators. It also gives advice on how to make the right purchasing decisions in selecting/acquiring comparators and avoid costly delays in comparator trials. More.
ISPE Good Practice Guide on Non-Investigational Medicinal Products under Development
No complete regulation or guideline exists for Non-Investigational Medicinal Products (NIMPs). For this reason, companies may either overcomplicate their clinical trials by submitting products as IMPs when they could be managed as NIMPs. Alternatively, companies may file the clinical trial products as NIMPs only to be denied by a health authority later in the process. ISPE is developing a Good Practice Guide on the definition and use of NIMPs to alleviate the perceived regulatory and operational ambiguity surrounding NIMPs.
Messages from the IP North American and European Chairs
Steve Yoder, Chair of the IP North American Steering Committee, and Esther Sadler-Williams, Chair of the IP European Steering Committee, introduce themselves and discuss the work ahead for this global IP community. More. ( 53 KB)
ISPE to Develop Guide on Clinical Supply Information Systems: Call for Volunteers
The ISPE Investigational Products Community of Practice (IP COP) is sponsoring an effort to develop a Guide on Clinical Supply Information Systems. Members from pharmaceutical and biotechnology companies and contract service providers are invited to participate on the task team. More.
IP COP Launches LinkedIn Group
The IP COP recently launched a LinkedIn Group to help improve ability to share information and engage in active discussions. The IP COP hopes you will join the dialogue and take an active part in the group. Feel free to initiate new discussions and comment on existing topics. LinkedIn Group discussions are preferable to email because the conversations remain on the database and are readily retrievable by searching at a later date. Individuals participating in the group may also receive notifications as the discussions progress via email.
How do you join? If you are already a member of LinkedIn, go to the pull down menu in the upper right hand corner located on the main page and select “Groups,” then type “ISPE – IP COP” into the search box. Select the ISPE – IP COP and when the page associated with our group appears, click the yellow “Join Group” button. The IP COP looks forward to seeing you soon on the message board!
Mission Critical: Supply Chain Optimization in a Regulated Environment
The Investigational Products educational session at the 2011 Annual Meeting (6-9 November, Texas, USA) will be “Mission Critical: Supply Chain Optimization in a Regulated Environment.” This session, to be held 7-9 November, will address challenges that industry professionals face in their day-to-day lives, as well as provide a crystal ball look into potential changes in the pharma industry and how they may impact the planning and execution of clinical supplies. The session will be highly interactive and offer many opportunities for participants to apply their own perspectives, as well as take away actionable solutions. More.
Status of Interactive Response Technology Good Practice Guide
The initial draft of the Interactive Response Technology Good Practice Guide (IRT GPG) has been created and will be sent to industry colleagues and regulators for review and comment. Upon completion of the review, appropriate updates will be made to the document and then a final version will be prepared. Current plans are to have the final document available for issuance at the ISPE 2011 Annual Meeting.
Members of the GPG Core Task Team have been invited to meet with the EMA GCP Inspectors Working Group in September for further discussions; the Group has been very helpful to the IP COP since the beginning of the COP’s efforts. The IP COP looks forward to sharing the outcome of these discussions at the Annual Meeting, where it will be joined by one of the members of the EMA.
Now Available – ISPE Good Practice Guide (GPG): Cold Chain Management
This GPG covers a wide range of topics, including facilities, fixed cold rooms and freezers, temperature controlled shipping equipment, as well as guidance on mapping and monitoring, featuring practical technical guidance in all these areas, as well as addressing maintenance and cleaning. The guide also includes an introduction to product traceability. Cold chain is an area with increasing challenges to manufacturers, as the volume of products requiring controlled temperatures and the complexity of the supply chain for those products increase. The GPG provides practical guidance and examples of typical documents in the area of cold chain management. More.
IP Session at Annual Meeting a Success
The Investigational Products session, "A Magical Journey to Explore Reality, Retooling and Growth,” at the ISPE Annual Meeting held in November 2010 in Orlando, Florida, USA, was a huge success. The three day session addressed topics that covered challenges that industry professionals face in their day-to-day lives as well as a keynote address discussing business drivers for in-sourcing vs. outsourcing with presentations from Eli Lilly and Merck. The more than 100 registrants also learned how to identify and hire clinical supply personnel, apply Lean Six Sigma to key critical processes, develop a configurable IWRS, fit for purpose GMP's, and the ever popular wildcard session, where discussions focused on removal of expiry dates from labels, challenges of validating an IVR system, changes to Annex 13 and comparator sourcing. The IP Community looks forward to seeing you at the: 2011 ISPE Annual Meeting 6-9 November in Dallas, Texas, USA.
Survey to Measure IP Community Needs
The IP COP North America Steering team is currently working on an initiative to better understand the needs and topics of interest of our Community of Practice membership. In order to help us achieve that objective we have developed this survey designed to measure the level of interest and need for more information in the IP community on a list of topics. Your input is important to us. Your responses will drive the direction the steering committee takes going forward to develop knowledge briefs, webinars, training development, articles, and other information for our members.
Please invest some time in indicating your level of interest and need for more information on each of the following topics: Take Survey
What the IP Community is Discussing Right Now
For an investigational oral solid dosage form, does your company typically generate an MSDS on the drug product or only on the drug substance? Your colleagues would like to hear your thoughts on this and other topics under the Community Discussions section of the IP Community of Practice site. Read more.
Brussels Report: Lean and Compliant? Applying Efficient Tools to a Regulated Clinical Supply
A report provides a summary of highlights from the ISPE Brussels Conference affecting the Investigational Products community. Read more.
IVRS Task Team Update
A report highlights the current progress and goals of the IP COP’s Interactive Voice Response Systems (IVRS) Task Team. Read more.
What to Expect from IP at Annual Meeting
The IP COP North America Steering committee is feverishly finalizing the presentations for the upcoming ISPE Annual Meeting in Orlando, Florida, 7-10 November. We have a very exciting agenda planned. This year’s theme is “Discovering What’s Next: Reality, Retooling, Growth.”
Some of the exciting workshop topics are:
And many more!
Sign up early to make sure you don’t miss out!
IP COP Members to Receive Topics of Interest Survey
The IP COP North America Steering team is currently working on an initiative to better understand the needs and topics of interest of our Community of Practice membership. In order to help us achieve that objective we are developing a survey that we will electronically distribute to our members in the coming weeks. The survey is designed to measure the level of interest and need for more information on a list of IP-related topics. The responses will drive the direction the steering committee takes going forward to develop knowledge briefs, webinars, training development, articles, and other information for our members. Please take the time to respond and help us meet the needs of our members.
Chair, LINKS Sub Committee
IP Subject Matter Experts Needed for CPIP
The Exam Development Committee of the Professional Certification Commission (PCC) is in need of volunteers to write a few Investigational Products-oriented questions for ISPE's groundbreaking Certified Pharmaceutical Industry Professional (CPIP) certification exam. To date, 70 seasoned industry professional have provided questions, but more are needed. If you would be willing to give just a few hours of your time and share your valuable knowledge in the area of IP or other disciplines, please send your resume/CV to Michael Phelan at firstname.lastname@example.org.
New Drug Law in Russia Affects Clinical Research
The Russian State of Duma approved a new law, effective 1 September, that settles several matters related to contracts for clinical trials and includes new requirements. Read more.
EU IP COP Meeting 22-23 September, Brussels
This year the EU IP COP meeting will be in Brussels and we have a really exciting and challenging agenda. We have secured not one but two regulators to talk about their experiences around the GMP/GCP interface; with particular emphasis on their observations from clinical sites. We will also have input from a clinical site pharmacist and thereafter the audience will break into workshop groups to provide direct feedback to the regulators on what we can do “differently tomorrow” – giving us an opportunity to think about the impact on someone we sometimes might forget as we plan our complex protocols and packaging – the patient.
Other subjects being discussed at the meeting include Validation of IVR and a case study on an integrated IT system for clinical supply as well as a number of talks around our conference theme of application of “Lean” principles in clinical supply. The conference usually attracts clinical supply professionals from around the globe and is a mix of formal presentations and interactive workshops and will be a great opportunity to meet with colleagues old and new. We look forward to welcoming you!
Non IMP Task Team
With support from the council we have formed a new task team to look at that “thorny problem” of non IMPs/comparator medication. The goals of this task team are to be further defined but amongst its objectives will be to create a consensus on what the industry and regulators define as non IMPs and to create a guideline document around when to use local versus central procurement as well as re-imbursement and labeling approaches for these products.
What the IP Community is Discussing Right Now
“Standard” lead times for preparing clinical supplies and label compliance in different countries continue to be hot topics of discussion on the IP COP site. Read more.