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Free-to-access Webinars

Live & recorded webinars by leading pharmaceutical experts

Webinar

PTI has joined with leading experts in the pharmaceutical industry to bring you a variety of free-to-access webinars to provide you with a taster of what our training courses can offer. Our webinars range from 5 – 30 minutes and cover a wide range of topics including Biological Assays, Clinical Trials and EMEA Guideline. We run these interactive live webinars every month which we then upload to our YouTube Channel and website.

Benefits of PTI webinars:

  • Free registration
  • Q&A session with webinar trainer
  • Exclusive insight into topical content

For sponsorship enquiries regarding our webinars, please contact Michael Hanton via Michael.Hanton@informa.com or +44 20 701 76406.


Upcoming webinars:

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UPCOMING FREE WEBINAR SERIES

Webinar 1: 7 Sep - The effect of the contract on performance
Common sponsor concerns about partner performance, things that make people perform at their best, practical tips on getting it right

Webinar 2: 19 Sep - A process for managing change
The 8 step approach to change, guides in managing change, example of process in action

REGISTER FOR THE WEBINARS

pct digital week 1

Webinars. Webinars. Webinars.

That's right. KNect365 Life Sciences are offering you four days packed full of webinars! And what's more, it’s all completely free. So, get your questions at the ready, because each session will be followed by a live Q&A with the speakers.

REGISTER NOW

Free-to-access Webinars

setting up a minimum viable project charter and important associated factors

Title: Setting up a minimum viable project charter and important associated factors

This webinar is led by Ian Stokes, he is a project management practitioner, certified facilitator and trainer who delivers process and learning solutions to the pharmaceutical industry. He is the trainer for PTI's public and Online Academy courses on Clinical Research Project Management.

  • What is the project charter?
  • Defining roles, including the project sponsor
  • Adding further project compatibility – use of a “team charter”
  • Practical uses of the project charter – identifying the “wrong project”

Aspects of Comparability for Biologics

Over 30 minutes, this recorded webinar investigates:

• Impact of process changes for recombinant therapeutics
• When are comparability studies required
• Which scope is expected for biotech products
• Five steps to succeed in comparability

This webinar was ledby Dr Robert Zoubek, an expert in the development, manufacturing, and analytics of biologics, as well as regulatory affairs.

Dr Zoubek is the course leader for our popular course ‘Comparability for Biologics’ which begins on 18th July 2017.

This webinar was first broadcast live on 6th June 2017.

Risk Management for Clinical Outsourcing

Managing risk is essential in good oversight of a clinical trial. In this webinar, the following points were discussed:

• Risk Management for Outsourcing
• Risk Identification
• Risk Impact Mitigation through Risk Management
• Risk Management Plan

This session was led by Julianne Hull. Julianne has successfully held global leadership roles in vendor management/outsourcing and clinical operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen).

An Overview of CMC Analytical and Stability Studies Required for Biopharmaceutical Products

In around 40 minutes, this webinar covers:

  • Why developing biological/biotech/biosimilar products is so challenging
  • What world-wide regulations detail CMC analytical study requirements
  • The success factors in developing and commercialising biotech/biosimilar products

This webinar was led by Nadine Ritter, trainer for 'CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products' courses.

Management of your Vendors - Sponsor Responsibility

This webinar explores upcoming changes to Sponsor responsibility with the latest developments in ICH E6 Revision 2.

Over c.30 minutes, learn about the following: 
• Understand the ICH E6 Revision 2 changes 
• Explore how this will place a greater emphasis on Vendor oversight 
• Investigate ways to navigate these changes for Sponsors 

Led by John Shillingford, trainer for PTI's Effectively Managing Vendor Oversight training course.

Assay Development – From Scratch to Validated Assays

Over 30 minutes, this webinar will explore the essentials of assay development:

  • Critical factors in assay development
  • Immuno-versus bioassays
  • Design of experiments
  • Matrix interference

This webinar will be led by Melody Sauerborn, trainer for day 1 of Analysing Bioassays and Immunoassays.

Specifications for Small Molecule Drug Products Webinar

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.

The webinar will cover: 
• Regulatory guidance (ICH, FDA, EMA) 
• Tests appropriate to different dosage forms 
• Dissolution specifications for immediate-release, modified-release and extended-release drug products 
• Dissolution specifications in the context of the biopharmaceutical classification system 
• Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination 
• Specifications for combination drug products 
• The role of specifications in maximizing drug product stability

 Analysis and Validation of Biological assays

Led by Melody Sauerborn, this high-level 30 minute webinar provides practical insights into the analysis validation of biological assays. Watch the archived webinar and gain a solid grounding in the basics of biological assays, discover valuable methodology and examine useful validation/qualification techniques.


To find out more about one of our training courses on this topic, please visit our course website.

A Holistic Approach to Managing Quality During a Trial

In this concise webinar Peter outlines the the four essential areas to enable you to effectively manage quality during a clinical trial.


To find out more about one of our training courses on this topic, please visit our course website.

 EMEA Guideline on the limits of Genotoxic Impurities

Andrew Teasdale presents this short webinar about the EMEA Guideline on the limits of Genotoxic Impurities.


To find out more about one of our training courses on this topic, please visit our course website.

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool

Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores hot to optimise IVIVC using your dissolution data.


Topics covered:

  • Basis of IVIVC
  • Why IVIVC and dissolution are important
  • Use in development: interest and limitations
  • Optimisation of formulation based on IVIVC
  • Conclusions and Q&A session

To find out more about one of our training courses on this topic, please visit our course website.

Risk Based Monitoring QbD and Protocol Design Webinar

 In this short but informative webinar, Peter provides practical advice on designing protocol writing rules.


To find out more about one of our training courses on this topic, please visit our course website.

Overview of CMC Biotechnology

 Dr Nadine Ritter presents this webinar focusing on the following aspects of CMC Biotechnology:

Examining the major analytical and stability differences between small molecule and biotech products
Exploring CMC timelines for biotech products
Special focus on breakthrough/fast-track products on CMC timelines
Assess how analytical studies are so front-end loaded for biosimilar products

To find out more about one of our training courses on this topic, please visit our course website.

Webinar Topic Suggestions

Please feel free to contact us with any ideas for future webinar topics.


Please email Roisin Manning (Roisin.Manning@informa.com). Webinar ideas are subject to approval and appropriate trainer availability.