A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Presented by
Simon Day (CTCT Limited)
and
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Pharmacokinetics
Introduction
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
Sample size
Regulatory guidance
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Registration
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
Contact: Emma Lovett, Tel: +44 (0)845 180349 Email: PSI@mci-group.com
Scientific Meetings
Introduction to Pharmacokinetics & Bioequivalence
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Presented by
Simon Day (CTCT Limited)
and
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Pharmacokinetics
Introduction
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
Sample size
Regulatory guidance
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Registration
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
Contact: Emma Lovett, Tel: +44 (0)845 180349 Email: PSI@mci-group.com
Training Courses
Introduction to Pharmacokinetics & Bioequivalence
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Presented by
Simon Day (CTCT Limited)
and
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Pharmacokinetics
Introduction
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
Sample size
Regulatory guidance
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Registration
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
Contact: Emma Lovett, Tel: +44 (0)845 180349 Email: PSI@mci-group.com
Journal Club
Introduction to Pharmacokinetics & Bioequivalence
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Presented by
Simon Day (CTCT Limited)
and
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Pharmacokinetics
Introduction
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
Sample size
Regulatory guidance
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Registration
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
Contact: Emma Lovett, Tel: +44 (0)845 180349 Email: PSI@mci-group.com
Webinars
Introduction to Pharmacokinetics & Bioequivalence
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Presented by
Simon Day (CTCT Limited)
and
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Pharmacokinetics
Introduction
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
Sample size
Regulatory guidance
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Registration
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
Contact: Emma Lovett, Tel: +44 (0)845 180349 Email: PSI@mci-group.com
Careers Meetings
Introduction to Pharmacokinetics & Bioequivalence
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Presented by
Simon Day (CTCT Limited)
and
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Pharmacokinetics
Introduction
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
Sample size
Regulatory guidance
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Registration
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
Contact: Emma Lovett, Tel: +44 (0)845 180349 Email: PSI@mci-group.com
Upcoming Events
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Topic: R Package Basics.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.