Introduction to the Pharmaceutical Industry
Critical Issues in Clinical Trial Administration
GCP Compliance in Document Management
Essential GCP Updates - EU CT Directive/Ethics Matters
How to Successfully Pass an Audit
Effective Study Site Management
How to Prepare your Sites for Audit
Essential Auditing Skills
Understanding Ethics Committees
Phlexglobal is interested in getting the right knowledge to the right people at the right time through a collection of technologies, tools and philosophies. We see knowledge as an object that can be captured and transferred. We see that transfer as a process that is unique to each individual. And we recognise that knowledge transfer is not just one initiative, it's the integration of many initiatives working together. Effective learning at Phlexglobal integrates elements of our Core Business Skills packages into our Knowledge-centred courses to ensure optimal learning outcomes.
The five courses detailed below focus on knowledge. Whether you are completely new to the industry or you have many years experience behind you, we are careful to address your specific training needs. The only constant in our industry is change and information giving and gathering is an absolute requirement.
All these courses are delivered as dedicated one-day events, however
they can be blended with Skills-based learning to ensure additional
benefit should the client/delegate be interested in tailor-made training
solutions.
Introduction to the Pharmaceutical Industry
Different Departments in a Pharmaceutical Company
Phases of a Clinical Trial (I – IV)
The Critical Path of a Clinical Trial
The Clinical Trial Administrator within a Clinical Research Team
Good Clinical (Research) Practice – legislation, regulation,
guidelines.
Standard Operation Procedures
Trial Master File & Essential Documents
Serious Adverse Events
Checklists and Tracking – when, where, what?
Audit, QA and QC
Archiving and Document Management
Understanding Statistics and Data Management
External Relationships, e.g. Central Laboratory, Pharmacy, Investigators
&
The skills you will need to develop to be successful…
We offer this course in two formats. The first as a dedicated introduction for personnel already involved with the industry that need to be brought up to speed rapidly and effectively. Secondly, we have developed the same material in a way that will suit administrators and new graduates looking for employment in the industry. Recognising the importance of this course in launching or changing your career this course is only £150 to new secretaries/administrators and new graduates (subject to suitable references).
2008 dates:
30th January
27th February
26th March
30th April
28th May
25th June
30th July
27th August
24th September
29th October
26th November
17th December
Fee- £150 per delegate + VAT
The Critical Path of a Clinical Trial – Phases, Key Milestones
Regulatory Issues - EUCTD, Declaration of Helsinki, etc.
Ethics Committee Submissions – Planning, Timelines, Follow-up
Meetings - Investigator, Monitor, Conferences, Training
Clinical Trial Logistics - Document Management, Tracking, Archiving,
Audits/Inspections – Preparation, Participation, Outcomes
Relationships – Internal/External, Teamwork, Study Site Liaison
Personal Development – Careers, Training Records & Personal
Plans, Choices.
Delegates identify the Good Clinical (Research) Practice issues that significantly affect them and work on predicting the issues for tomorrow. With particularly attention being paid to the new EU CT Directive, especially regarding regulatory and ethical considerations, consent and confidentiality, essential documents and the trial master file, delegates will be able to provide practical resolutions through shared experience and workshop activities. Emphasis will be given to the importance of document management in clinical trials, including planning for archive and, critically, preparing for audits/inspections. The course also centres on the evolving role of the Career CTA and will cover specialist areas such as operational diversification (Meetings Co-ordination, Ethics Committee Submission) and man-management duties (CTA Supervision). Time will be spent addressing critical issues in liaison, interaction and teamwork with other clinical team members (e.g. CRAs, Data Managers, Pharmacovigilance) and external partners (e.g. Investigator Sites, Pharmacy, Laboraties).
2008 dates:
20th February
16th July
22nd October
Fee- £385 per delegate + VAT
GCP Compliance in Document Management
This is the essential course for CRAs, CTAs, Archivists and anyone
involved in the Management of Clinical Trial Documentation. The course
runs for one-day and can be customised to suit your own specific
archiving and document management needs addressing the following
subjects-
EU CT Directive, Declaration of Helsinki, Data Protection Act
GCP Issues – Consent, Ethics and Essential
Documents Archiving – The Why/What and When?
Electronic Records Management
Investigator Archiving
Audits/Inspections
&
Archiving and Retention Requirements by GCP/EUCTD and Regulatory Authorities
Preparation of Documents for Archiving
Tracking of Archived Documents
Requirements of Archives for Long-Term Storage
How to select a suitable off-site storage Company
What the Inspectors expect
Alternative Long-term Storage Media
Electronic Archiving
2008 dates:
28th February
21st May
11th September
10th December
Fee- £385 per delegate + VAT
Please email JHarford@icr-global.org to register for this course.
The impact of the EU Clinical Trials Directive is already visible as everyone involved in Clinical Research puts in place action plans to cope with and embrace the changes. Phlexglobal is no exception. We include in all our Knowledge-centred courses specific elements to update and inform delegates of all significant issues, whether historical, active, or predicted. Any company conducting a clinical trial in Europe must adhere to the new regulation as interpreted by the different EU Member States from May 2004. A clear understanding of the true practicalities of implementation is included, along with practical compliance solutions for each case discussed. Furthermore, we understand that all of us need to fully realize the challenges and opportunities presented by the Directive to ensure that our Industry’s compliance strategies maximize the Directive's advantages whilst prepare for the stumbling blocks it may present. Our focus will examine key aspects of the Directive's implementation and the impact on drug companies at the macro level as well as looking in detail at the changes that will roll down at the micro level, i.e. the effect on the individual within the Clinical research environment. This includes examining how the Directive interfaces with ICH GCP and FDA regulations and the consequences on: multi site/multi country trials; Phase I trials; Ethics management, compliance with GMP for Investigation Medicinal Products; and meeting application procedures for regulatory authorities. Where appropriate we also examine the role, functionality and practicalities of the EUDRACT and SUSAR databases and their implications.
This course ensures delegates are as up-to-date as possible with the latest changes affecting the submission process, and to gain practical advice that assists in improving the quality of submissions.
The EU CT Directive - Where are we now?
Governance Arrangements for Research Ethics Committees (GAFREC)
Timelines on submissions
Preparing the submission
A guide through the forms
Forward Planning
Getting it right
Quality Issues
What would the Inspectors look for?
2008 dates:
16th April
15th October
This essential training can be adapted and tailor-made to suit your own department’s needs as either a half day or full day course – Dates and Fees on application.
The Most Essential Training for all Clinical Research Personnel
According to clinical research convention audit is defined as a “systematic and independent examination of trial related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data recorded, analysed and accurately reported according to the protocol, sponsor’s SOP, Good Clinical Practice and the applicable regulatory requirements”. For those who have never experienced or been involved with an audit, there is often a mystique and even an anxiety associated with the process. Audits need not be intimidating if the work has been done to prepare for them.
The Most Experienced Auditors & Trainers in Industry Today
Audit is described as a means by which the sponsor exercises its responsibility for managing quality and integrity of clinical research projects. Audit should be seen as an objective means of determining, rather than leaving to guesswork, whether the subject under audit did comply with the necessary requirements at the time of assessment. Our trainers have the experience to guide you through an audit fro start to finish. With over four decades of experience between them across over 700 audits, in over 20 countries our trainers, Nigel Crossland and Gareth Hayes have put theory into practice many times.
The Most Effective Way of Preparing for Audit & Inspection
Audits are in-depth examinations of facilities, procedures and documents with the intention of forming conclusions about performance. Whether involved with audit of studies, systems, facilities or processes, the essential methodology remains the same. The life of an audit begins with the preparation of the audit plan. This is often thought to be the sole domain of the auditor performing the audit. However, if you are being audited, the best way to begin to relieve your anxieties is to prepare your own audit plan, your audit strategy. This course allows you to explore, in-depth, how your audit strategy will be successful. It will benefit everyone in clinical research who is involved in the audit process whether you are from industry (e.g. CRA, CTA, Line Manager) or from Healthcare Services (e.g. SSC, Research Nurse, Pharmacist)
This interactive one-day workshop will cover:
Purpose of audit, preparations and communications, background (who, what, where, why, how), audit plans, scope/depth, audit composition (interview, documentation, facilities), introductory & exit meetings, written audit report, written audit responses, case studies and examples, source v transcribed data, data capture systems, laboratory data, equipment, training records, quality control, follow-up and feedback, learning outcomes.
Make yourself “Fit for Purpose”!
2008 dates:
2nd April
6th November
Fee- £385 per delegate + VAT
Coming Soon: A brand new course delivered by expert trainers from Pharma and from the Study Site!
2008 dates on application
Coming Soon: A brand new course delivered by expert trainers from Pharma and from the Study Site!
2008 dates on application
Booking Forms and Registration
Contact Carla Ashley on 01494 720420 or e-mail training@phlexglobal.com.
Coming Soon: A brand new course delivered by expert trainers and auditors.
2008 dates:
4th June
Booking Forms and Registration
Contact Carla Ashley on 01494 720420 or e-mail training@phlexglobal.com.
Coming Soon: A brand new course delivered by expert trainers and auditors.
2008 dates:
3rd April
16th October
Booking Forms and Registration
Contact Carla Ashley on 01494 720420 or e-mail training@phlexglobal.com.