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2016 Workshops

Importer of Record: The Ins & Outs of Global Distribution Workshop
1
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.
QP Update : How are clinical trial requirements changing in the EU? Workshop
2
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.
Movement of Clinical Trial Materials between Investigational Sites Workshop
3
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.
Mitigating Risk in Direct-to-Patient Clinical Trials Workshop
4
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.
Expanded Access Trials – Turning “Compassionate Use” into a Global Strategy Workshop
5
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.
Drug Supply Management for Investigator Sponsored or Investigator Initiated Studies Workshop
6
This workshop will discuss the challenges and program management requirements for maintaining control when conducting Investigator Initiated Trials globally.
Career Planning and Transition Management Workshop
7
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.
Managing Temperature Excursion Times Workshop
8
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.
Labelling Challenges for Small Containers Workshop
9
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.
 Managing Returns Workshop
10
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.
Procuring and Distributing Ancillary Supplies Workshop
11
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.
Differences in International Regulatory Requirements Workshop
13
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.
Leadership, Coaching and Mentoring of Clinical Supplies Personnel Workshop
14
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.
Options for Pooling Clinical Supplies Workshop
15
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.
Requirements for Declaring Material IMP vs NIMP Workshop
16
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.
JIT Labeling Workshop
17
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.
Organizational Structures for Clinical Supplies Groups Workshop
18
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.
Long Distance Shipments Workshop
19
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.
Advantages of TransCelerate Membership Workshop
20
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.
Blinding Comparators – What Can You Do To That Other Company’s Drug? Workshop
21
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.
eLabeling – A Demonstration Workshop
22
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.

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