Day 1 : Sunday, April 24
9:00 am - 3:30 pm
Clinical Supplies 101 (Boot Camp)
This 6 hour long class is geared toward people new to the clinical trial supplies world. Attendees will be provided with an overview of drug development and what goes into planning for and delivering the study drug for a clinical trial. Included in the training will be the reason behind cGMPs, phases of new drug development and approval, randomizing and blinding clinical trial materials, Quality Assurance & documentation, protocol interpretation, patient CTM compliance, labeling, SOPs, stability, Good Distribution Practices, returned drug accountability, and changing regulations in the EU and ROW. This is an informal workshop that will give attendees a massive amount of information in a fun and interactive atmosphere.
Day 2 : Monday, April 25
10:10 am - 11:10 am
Blinding Comparators (WS21)
Blinding drugs has become exponentially more difficult over the years. With the advent of controlled release products and injectables, our ability to ensure no bias is introduced into our studies has become more and more challenging. This presentation will discuss options and ideas for blinding various dosage forms.
10:10 am - 11:10 am
Direct to Patient Trials (WS4)
With an increase in the number of worldwide studies and with more clinical protocols involving biologics coupled with the increased pressure to recruit and retain patients in addition to optimizing patient compliance, new and innovative ways need to be found to customize IMP closer to the patient as well as supporting the delivery of clinical supplies to patients homes. This workshop will discuss summarize the benefits and risks as well as practical approaches to implementing strategies to support these concepts.
10:10 am - 11:10 am
eLabelling (WS22)
In the ever changing world of clinical supplies, labeling (other than booklet labels) has not changed very much at all. With the evolution of smartphones and the cloud, new technologies have begun to emerge that could save time and relabeling costs. The concept of bar code scanning, e-labeling, and near field communication (NFC) with chips are some of the options that are under investigation. This presentation will discuss how eLabeling works, what advances have been made to standardize it, and enable approval by regulatory agencies.
10:10 am - 11:10 am
IIT/ IIRs (WS6)
This workshop will discuss the challenges and program management requirements for maintaining control when conducting Investigator Initiated Trials globally.
10:10 am - 11:10 am
IMP vs NIMP (WS16)
Ever been confused about the differences between Investigational Medicinal Products (IMPs) and non-Investigational Medicinal Products (nIMPs)? This workshop will be a discussion of the requirements for classifying clinical materials as IMPs or nIMPs. The regulatory implications as well as the impact on clinical supplies will also be considered.
10:10 am - 11:10 am
JIT Labeling (WS17)
Despite the obvious advantages, just-in-time (JIT) labeling is still not widely used across the pharmaceutical industry. This workshop will contain a discussion of the barriers slowing the acceptance of JIT and what can be done to overcome them.
10:10 am - 11:10 am
Leadership, Coaching and Mentoring (WS14)
In the world of clinical supplies and clinical development, technical skills were often more valued than leadership and management skills. That is changing rapidly as change management, partnerships, business acumen, and career success and longevity require high levels of leadership and management skills. With workforces getting more diverse and teams becoming global and virtual/remote, coaching and mentoring skills have now become crucial for success. This workshop will identify 7 leadership traits necessary for your growth and success and 2 simple yet important skills for coaching and mentoring.
10:10 am - 11:10 am
Managing Returns (WS10)
Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
10:10 am - 11:10 am
Managing Temp Excursion Times (WS8)
The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the various ways the time "out of label storage conditions" can be better established and managed.
10:10 am - 11:10 am
Movement of CTM between Sites (WS3)
Ever run short on IMPs and wish you could transfer patient kits from one site to another? The requirements and planning necessary to redistribute IMP to another location where it is needed vary greatly between companies. This workshop will discuss the various practices used across the industry for moving clinical supplies between clinical sites.
10:10 am - 11:10 am
Org Structures for CS Groups (WS18)
Clinical Supplies Groups can be organized by structure, function, or even centers of excellence. This workshop will discuss how CT groups are organized, dive into why, discuss the advantages and disadvantages of each, and provide an opportunity to benchmark across the industry.
10:10 am - 11:10 am
Pooling Clinical Supplies (WS15)
Supplying multiple clinical trials from a pooled inventory of material provides a number of time and cost advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared, used, and accepted by your Quality Assurance & Clinical Operations partners.
10:10 am - 11:10 am
QP Update (WS2)
The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations. This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.
1:00 pm - 2:00 pm
Ancillary Supplies (WS11)
Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.
1:00 pm - 2:00 pm
Blinding Comparators (WS21)
Blinding drugs has become exponentially more difficult over the years. With the advent of controlled release products and injectables, our ability to ensure no bias is introduced into our studies has become more and more challenging. This presentation will discuss options and ideas for blinding various dosage forms.
1:00 pm - 2:00 pm
Career Planning and Transition Management (WS7)
The days of having a job for life are long gone. With the frantic pace of our jobs and our lives it becomes essential to have a plan in place to manage our careers and grow within, and sometimes without, our companies. This workshop will discuss tips and techniques to get a handle on your career and how to get the most out of it to provide greater satisfaction and a modicum of work-life balance.
1:00 pm - 2:00 pm
Differences in Int'l Reg Requirements (WS13)
Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will contain a discussion comparing the regulatory requirements of a variety of countries as well as how they impact CT supplies timelines and planning.
1:00 pm - 2:00 pm
Direct to Patient Trials (WS4)
With an increase in the number of worldwide studies and with more clinical protocols involving biologics coupled with the increased pressure to recruit and retain patients in addition to optimizing patient compliance, new and innovative ways need to be found to customize IMP closer to the patient as well as supporting the delivery of clinical supplies to patients homes. This workshop will discuss summarize the benefits and risks as well as practical approaches to implementing strategies to support these concepts.
1:00 pm - 2:00 pm
Expanded Access Trials/ Comp Use (WS5)
Many government agencies have recently created regulations that allow for using non-marketed drugs in life-threatening situations where clinical protocols do not exist. Commonly known as "compassionate use", there are a variety of classifications depending on the region across the world. This workshop will provide a discussion of the various types of scenarios under the Expanded Access umbrella with examples of how to prepare for the increase in demands they will generate.
1:00 pm - 2:00 pm
Importer of Record (WS1)
Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.
1:00 pm - 2:00 pm
JIT Labeling (WS17)
Despite the obvious advantages, just-in-time (JIT) labeling is still not widely used across the pharmaceutical industry. This workshop will contain a discussion of the barriers slowing the acceptance of JIT and what can be done to overcome them.
1:00 pm - 2:00 pm
Labelling Challenges for Small Containers (WS9)
Ever try to comply with the labeling requirements of Annex 13 on a 3cc vial? Including all of the required label text can be challenging. This workshop will compare the text requirements across various countries as well as options for meeting those requirements for a variety of small package types.
1:00 pm - 2:00 pm
Movement of CTM between Sites (WS3)
Ever run short on IMPs and wish you could transfer patient kits from one site to another? The requirements and planning necessary to redistribute IMP to another location where it is needed vary greatly between companies. This workshop will discuss the various practices used across the industry for moving clinical supplies between clinical sites.
1:00 pm - 2:00 pm
Org Structures for CS Groups (WS18)
Clinical Supplies Groups can be organized by structure, function, or even centers of excellence. This workshop will discuss how CT groups are organized, dive into why, discuss the advantages and disadvantages of each, and provide an opportunity to benchmark across the industry.
1:00 pm - 2:00 pm
TransCelerate Update (WS20)
TransCelerate BioPharma was started to enable collaboration across the pharmaceutical industry to enhance the development of new medicines. This workshop will be a discussion of the various initiatives TransCelerate is undertaking.
2:15 pm - 3:15 pm
Differences in Int'l Reg Requirements (WS13)
Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will contain a discussion comparing the regulatory requirements of a variety of countries as well as how they impact CT supplies timelines and planning.
2:15 pm - 3:15 pm
eLabelling (WS22)
In the ever changing world of clinical supplies, labeling (other than booklet labels) has not changed very much at all. With the evolution of smartphones and the cloud, new technologies have begun to emerge that could save time and relabeling costs. The concept of bar code scanning, e-labeling, and near field communication (NFC) with chips are some of the options that are under investigation. This presentation will discuss how eLabeling works, what advances have been made to standardize it, and enable approval by regulatory agencies.
2:15 pm - 3:15 pm
Expanded Access Trials/ Comp Use (WS5)
Many government agencies have recently created regulations that allow for using non-marketed drugs in life-threatening situations where clinical protocols do not exist. Commonly known as "compassionate use", there are a variety of classifications depending on the region across the world. This workshop will provide a discussion of the various types of scenarios under the Expanded Access umbrella with examples of how to prepare for the increase in demands they will generate.
2:15 pm - 3:15 pm
IIT/ IIRs (WS6)
This workshop will discuss the challenges and program management requirements for maintaining control when conducting Investigator Initiated Trials globally.
2:15 pm - 3:15 pm
IMP vs NIMP (WS16)
Ever been confused about the differences between Investigational Medicinal Products (IMPs) and non-Investigational Medicinal Products (nIMPs)? This workshop will be a discussion of the requirements for classifying clinical materials as IMPs or nIMPs. The regulatory implications as well as the impact on clinical supplies will also be considered.
2:15 pm - 3:15 pm
Importer of Record (WS1)
Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.
2:15 pm - 3:15 pm
Leadership, Coaching and Mentoring (WS14)
In the world of clinical supplies and clinical development, technical skills were often more valued than leadership and management skills. That is changing rapidly as change management, partnerships, business acumen, and career success and longevity require high levels of leadership and management skills. With workforces getting more diverse and teams becoming global and virtual/remote, coaching and mentoring skills have now become crucial for success. This workshop will identify 7 leadership traits necessary for your growth and success and 2 simple yet important skills for coaching and mentoring.
2:15 pm - 3:15 pm
Managing Returns (WS10)
Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
2:15 pm - 3:15 pm
Managing Temp Excursion Times (WS8)
The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the various ways the time "out of label storage conditions" can be better established and managed.
2:15 pm - 3:15 pm
QP Update (WS2)
The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations. This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.
2:15 pm - 3:15 pm
TransCelerate Update (WS20)
TransCelerate BioPharma was started to enable collaboration across the pharmaceutical industry to enhance the development of new medicines. This workshop will be a discussion of the various initiatives TransCelerate is undertaking.
Day 3 : Tuesday, April 26
10:00 am - 11:00 am
Ancillary Supplies (WS11)
Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.
10:00 am - 11:00 am
Blinding Comparators (WS21)
Blinding drugs has become exponentially more difficult over the years. With the advent of controlled release products and injectables, our ability to ensure no bias is introduced into our studies has become more and more challenging. This presentation will discuss options and ideas for blinding various dosage forms.
10:00 am - 11:00 am
Career Planning and Transition Management (WS7)
The days of having a job for life are long gone. With the frantic pace of our jobs and our lives it becomes essential to have a plan in place to manage our careers and grow within, and sometimes without, our companies. This workshop will discuss tips and techniques to get a handle on your career and how to get the most out of it to provide greater satisfaction and a modicum of work-life balance.
10:00 am - 11:00 am
Differences in Int'l Reg Requirements (WS13)
Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will contain a discussion comparing the regulatory requirements of a variety of countries as well as how they impact CT supplies timelines and planning.
10:00 am - 11:00 am
IIT/ IIRs (WS6)
This workshop will discuss the challenges and program management requirements for maintaining control when conducting Investigator Initiated Trials globally.
10:00 am - 11:00 am
JIT Labeling (WS17)
Despite the obvious advantages, just-in-time (JIT) labeling is still not widely used across the pharmaceutical industry. This workshop will contain a discussion of the barriers slowing the acceptance of JIT and what can be done to overcome them.
10:00 am - 11:00 am
Labelling Challenges for Small Containers (WS9)
Ever try to comply with the labeling requirements of Annex 13 on a 3cc vial? Including all of the required label text can be challenging. This workshop will compare the text requirements across various countries as well as options for meeting those requirements for a variety of small package types.
10:00 am - 11:00 am
Movement of CTM between Sites (WS3)
Ever run short on IMPs and wish you could transfer patient kits from one site to another? The requirements and planning necessary to redistribute IMP to another location where it is needed vary greatly between companies. This workshop will discuss the various practices used across the industry for moving clinical supplies between clinical sites.
10:00 am - 11:00 am
Org Structures for CS Groups (WS18)
Clinical Supplies Groups can be organized by structure, function, or even centers of excellence. This workshop will discuss how CT groups are organized, dive into why, discuss the advantages and disadvantages of each, and provide an opportunity to benchmark across the industry.
10:00 am - 11:00 am
Pooling Clinical Supplies (WS15)
Supplying multiple clinical trials from a pooled inventory of material provides a number of time and cost advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared, used, and accepted by your Quality Assurance & Clinical Operations partners.
10:00 am - 11:00 am
QP Update (WS2)
The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations. This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.
11:15 am - 12:15 pm
Blinding Comparators (WS21)
Blinding drugs has become exponentially more difficult over the years. With the advent of controlled release products and injectables, our ability to ensure no bias is introduced into our studies has become more and more challenging. This presentation will discuss options and ideas for blinding various dosage forms.
11:15 am - 12:15 pm
Direct to Patient Trials (WS4)
With an increase in the number of worldwide studies and with more clinical protocols involving biologics coupled with the increased pressure to recruit and retain patients in addition to optimizing patient compliance, new and innovative ways need to be found to customize IMP closer to the patient as well as supporting the delivery of clinical supplies to patients homes. This workshop will discuss summarize the benefits and risks as well as practical approaches to implementing strategies to support these concepts.
11:15 am - 12:15 pm
eLabelling (WS22)
In the ever changing world of clinical supplies, labeling (other than booklet labels) has not changed very much at all. With the evolution of smartphones and the cloud, new technologies have begun to emerge that could save time and relabeling costs. The concept of bar code scanning, e-labeling, and near field communication (NFC) with chips are some of the options that are under investigation. This presentation will discuss how eLabeling works, what advances have been made to standardize it, and enable approval by regulatory agencies.
11:15 am - 12:15 pm
Expanded Access Trials/ Comp Use (WS5)
Many government agencies have recently created regulations that allow for using non-marketed drugs in life-threatening situations where clinical protocols do not exist. Commonly known as "compassionate use", there are a variety of classifications depending on the region across the world. This workshop will provide a discussion of the various types of scenarios under the Expanded Access umbrella with examples of how to prepare for the increase in demands they will generate.
11:15 am - 12:15 pm
Importer of Record (WS1)
Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.
11:15 am - 12:15 pm
JIT Labeling (WS17)
Despite the obvious advantages, just-in-time (JIT) labeling is still not widely used across the pharmaceutical industry. This workshop will contain a discussion of the barriers slowing the acceptance of JIT and what can be done to overcome them.
11:15 am - 12:15 pm
Leadership, Coaching and Mentoring (WS14)
In the world of clinical supplies and clinical development, technical skills were often more valued than leadership and management skills. That is changing rapidly as change management, partnerships, business acumen, and career success and longevity require high levels of leadership and management skills. With workforces getting more diverse and teams becoming global and virtual/remote, coaching and mentoring skills have now become crucial for success. This workshop will identify 7 leadership traits necessary for your growth and success and 2 simple yet important skills for coaching and mentoring.
11:15 am - 12:15 pm
Long Distance Shipments (WS19)
When Clinical Supplies are molecularly fragile or require special handling or storage conditions, shipping them long distances and getting them there ready to be dosed can be challenging. This workshop will be a discussion of the various ways that IMP being transported long distances can be at risk and what to do to mitigate those risks.
11:15 am - 12:15 pm
Managing Returns (WS10)
Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
11:15 am - 12:15 pm
Managing Temp Excursion Times (WS8)
The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the various ways the time "out of label storage conditions" can be better established and managed.
11:15 am - 12:15 pm
QP Update (WS2)
The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations. This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.
11:15 am - 12:15 pm
TransCelerate Update (WS20)
TransCelerate BioPharma was started to enable collaboration across the pharmaceutical industry to enhance the development of new medicines. This workshop will be a discussion of the various initiatives TransCelerate is undertaking.
1:30 pm - 2:30 pm
Ancillary Supplies (WS11)
Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.
1:30 pm - 2:30 pm
Differences in Int'l Reg Requirements (WS13)
Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will contain a discussion comparing the regulatory requirements of a variety of countries as well as how they impact CT supplies timelines and planning.
1:30 pm - 2:30 pm
Direct to Patient Trials (WS4)
With an increase in the number of worldwide studies and with more clinical protocols involving biologics coupled with the increased pressure to recruit and retain patients in addition to optimizing patient compliance, new and innovative ways need to be found to customize IMP closer to the patient as well as supporting the delivery of clinical supplies to patients homes. This workshop will discuss summarize the benefits and risks as well as practical approaches to implementing strategies to support these concepts.
1:30 pm - 2:30 pm
Expanded Access Trials/ Comp Use (WS5)
Many government agencies have recently created regulations that allow for using non-marketed drugs in life-threatening situations where clinical protocols do not exist. Commonly known as "compassionate use", there are a variety of classifications depending on the region across the world. This workshop will provide a discussion of the various types of scenarios under the Expanded Access umbrella with examples of how to prepare for the increase in demands they will generate.
1:30 pm - 2:30 pm
IMP vs NIMP (WS16)
Ever been confused about the differences between Investigational Medicinal Products (IMPs) and non-Investigational Medicinal Products (nIMPs)? This workshop will be a discussion of the requirements for classifying clinical materials as IMPs or nIMPs. The regulatory implications as well as the impact on clinical supplies will also be considered.
1:30 pm - 2:30 pm
Labelling Challenges for Small Containers (WS9)
Ever try to comply with the labeling requirements of Annex 13 on a 3cc vial? Including all of the required label text can be challenging. This workshop will compare the text requirements across various countries as well as options for meeting those requirements for a variety of small package types.
1:30 pm - 2:30 pm
Leadership, Coaching and Mentoring WS14)
In the world of clinical supplies and clinical development, technical skills were often more valued than leadership and management skills. That is changing rapidly as change management, partnerships, business acumen, and career success and longevity require high levels of leadership and management skills. With workforces getting more diverse and teams becoming global and virtual/remote, coaching and mentoring skills have now become crucial for success. This workshop will identify 7 leadership traits necessary for your growth and success and 2 simple yet important skills for coaching and mentoring.
1:30 pm - 2:30 pm
Long Distance Shipments (WS19)
When Clinical Supplies are molecularly fragile or require special handling or storage conditions, shipping them long distances and getting them there ready to be dosed can be challenging. This workshop will be a discussion of the various ways that IMP being transported long distances can be at risk and what to do to mitigate those risks.
1:30 pm - 2:30 pm
Movement of CTM between Sites (WS3)
Ever run short on IMPs and wish you could transfer patient kits from one site to another? The requirements and planning necessary to redistribute IMP to another location where it is needed vary greatly between companies. This workshop will discuss the various practices used across the industry for moving clinical supplies between clinical sites.
1:30 pm - 2:30 pm
Org Structures for CS Groups (WS18)
Clinical Supplies Groups can be organized by structure, function, or even centers of excellence. This workshop will discuss how CT groups are organized, dive into why, discuss the advantages and disadvantages of each, and provide an opportunity to benchmark across the industry.
1:30 pm - 2:30 pm
Pooling Clinical Supplies (WS15)
Supplying multiple clinical trials from a pooled inventory of material provides a number of time and cost advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared, used, and accepted by your Quality Assurance & Clinical Operations partners.
Day 4 : Wednesday, April 27
10:00 am - 11:00 am
Blinding Comparators (WS21)
Blinding drugs has become exponentially more difficult over the years. With the advent of controlled release products and injectables, our ability to ensure no bias is introduced into our studies has become more and more challenging. This presentation will discuss options and ideas for blinding various dosage forms.
10:00 am - 11:00 am
IIT/ IIRs (WS6)
This workshop will discuss the challenges and program management requirements for maintaining control when conducting Investigator Initiated Trials globally.
10:00 am - 11:00 am
IMP vs NIMP (WS16)
Ever been confused about the differences between Investigational Medicinal Products (IMPs) and non-Investigational Medicinal Products (nIMPs)? This workshop will be a discussion of the requirements for classifying clinical materials as IMPs or nIMPs. The regulatory implications as well as the impact on clinical supplies will also be considered.
10:00 am - 11:00 am
Importer of Record (WS1)
Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.
10:00 am - 11:00 am
JIT Labeling (WS17)
Despite the obvious advantages, just-in-time (JIT) labeling is still not widely used across the pharmaceutical industry. This workshop will contain a discussion of the barriers slowing the acceptance of JIT and what can be done to overcome them.
10:00 am - 11:00 am
Labelling Challenges for Small Containers (WS9)
Ever try to comply with the labeling requirements of Annex 13 on a 3cc vial? Including all of the required label text can be challenging. This workshop will compare the text requirements across various countries as well as options for meeting those requirements for a variety of small package types.
10:00 am - 11:00 am
Leadership, Coaching and Mentoring (WS14)
In the world of clinical supplies and clinical development, technical skills were often more valued than leadership and management skills. That is changing rapidly as change management, partnerships, business acumen, and career success and longevity require high levels of leadership and management skills. With workforces getting more diverse and teams becoming global and virtual/remote, coaching and mentoring skills have now become crucial for success. This workshop will identify 7 leadership traits necessary for your growth and success and 2 simple yet important skills for coaching and mentoring.
10:00 am - 11:00 am
Managing Returns (WS10)
Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
10:00 am - 11:00 am
Managing Temp Excursion Times (WS8)
The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the various ways the time "out of label storage conditions" can be better established and managed.
10:00 am - 11:00 am
TransCelerate Update (WS20)
TransCelerate BioPharma was started to enable collaboration across the pharmaceutical industry to enhance the development of new medicines. This workshop will be a discussion of the various initiatives TransCelerate is undertaking.
11:15 am - 12:15 pm
Ancillary Supplies (WS11)
Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.
11:15 am - 12:15 pm
Career Planning and Transition Management (WS7)
The days of having a job for life are long gone. With the frantic pace of our jobs and our lives it becomes essential to have a plan in place to manage our careers and grow within, and sometimes without, our companies. This workshop will discuss tips and techniques to get a handle on your career and how to get the most out of it to provide greater satisfaction and a modicum of work-life balance.
11:15 am - 12:15 pm
Differences in Int'l Reg Requirements (WS13)
Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will contain a discussion comparing the regulatory requirements of a variety of countries as well as how they impact CT supplies timelines and planning.
11:15 am - 12:15 pm
eLabelling (WS22)
In the ever changing world of clinical supplies, labeling (other than booklet labels) has not changed very much at all. With the evolution of smartphones and the cloud, new technologies have begun to emerge that could save time and relabeling costs. The concept of bar code scanning, e-labeling, and near field communication (NFC) with chips are some of the options that are under investigation. This presentation will discuss how eLabeling works, what advances have been made to standardize it, and enable approval by regulatory agencies.
11:15 am - 12:15 pm
Expanded Access Trials/ Comp Use (WS5)
Many government agencies have recently created regulations that allow for using non-marketed drugs in life-threatening situations where clinical protocols do not exist. Commonly known as "compassionate use", there are a variety of classifications depending on the region across the world. This workshop will provide a discussion of the various types of scenarios under the Expanded Access umbrella with examples of how to prepare for the increase in demands they will generate.
11:15 am - 12:15 pm
Labelling Challenges for Small Containers (WS9)
Ever try to comply with the labeling requirements of Annex 13 on a 3cc vial? Including all of the required label text can be challenging. This workshop will compare the text requirements across various countries as well as options for meeting those requirements for a variety of small package types.
11:15 am - 12:15 pm
Long Distance Shipments (WS19)
When Clinical Supplies are molecularly fragile or require special handling or storage conditions, shipping them long distances and getting them there ready to be dosed can be challenging. This workshop will be a discussion of the various ways that IMP being transported long distances can be at risk and what to do to mitigate those risks.
11:15 am - 12:15 pm
Pooling Clinical Supplies (WS15)
Supplying multiple clinical trials from a pooled inventory of material provides a number of time and cost advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared, used, and accepted by your Quality Assurance & Clinical Operations partners.
11:15 am - 12:15 pm
QP Update (WS2)
The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations. This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.
