When: 4 - 6 December 2019
Where: De Vere Latimer Estate, Chesham, UK
Please note that accommodation at the venue is full. If you do decide to book you will have to find an alternative venue.
Start Day 1: 14:00 End Day 3: 16:00
Course overview
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of chemistry and pharmacy data. It will cover the regulatory requirements imposed on preparing chemistry and pharmacy data, as well as the processes of preparing chemistry and pharmacy documentation such as the Common Technical Document, IMPDs and INDs.
Lectures and workshops will cover the following:
- Understanding the application of modern approaches for preparing the chemistry and pharmacy development programme
- The latest requirements for the role of chemistry and pharmacy in the overall drug development programme
- The chemistry and pharmacy dossier format and structure in the EU and US
- Analytical methods and validation
- Manufacture of the drug products
- Quality control of specifications for the drug substance and drug product
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge.
Benefits to delegates
This course will enable you to:
- Display a systematic understanding of, knowledge of, and a critical awareness of the Chemistry and Pharmacy data requirements and interpretation during development of a new chemical active substance
- Gain a comprehensive understanding of good manufacturing processes in formulation and the validation requirements in the context of drug development
- Demonstrate conceptual understanding of the legal and regulatory requirements for the development of a new active substance including EU clinical directives, global legislation and guidelines to evaluate current research critically
- Demonstrate the ability to critically analyse the legal documentation and regulatory considerations for the chemistry and pharmacy data required for developing the specifications for the drug product
- Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate conclusions clearly to specialist and non-specialist audiences
- Critically appraise and evaluate communications from regulatory bodies and research publications covering chemistry and pharmacy data
CPD: This course provides 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Suitable for
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for a new active substance
- Delegates from allied industries who wish to have a comprehensive understanding of the subject
Students of the MSc and those working in regulatory affairs departments.
Programme
The latest course agenda can be downloaded here
Module Leader
Per Niklasson
Regulatory CMC Director and Regulatory CMC Global Regulatory Excellence, AstraZeneca, Sweden
Per Niklasson is an experienced Regulatory CMC Director with extensive line management experience and a demonstrated history of working in the pharmaceuticals industry. Per has been with AstraZeneca for 25 years. For the last 14 years he has worked as a line manager in Regulatory CMC in a true global organization. He has been involved in the development of several of the new drugs that AstraZeneca recently has launched. Before taking on a line manager role, Per worked for 10 years as a Reg CMC representative in both development projects and product maintenance. Significant achievements included Regulatory CMC responsibility for a drug called Nexium through development to global launches. This included several pharmaceutical formulations such as capsules, tablets, IV and sachets. Per graduated the TOPRA Diploma in Regulatory Affairs in 2000. Per obtained a MSc Chemical Engineering in 1991.
Presenters
TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies,notified bodies and other stakeholders, and are validated by the University of Hertfordshire.
Speakers for this course:
Mike James - Cambridge Regulatory
Christian Maasch - Xendo
Craig Donnelly - Mapi Strategic Services
Tahir Nazir - AstraZeneca
Torsten Kneuss - Bayer
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
|
Those working for regulatory agencies, government agencies or academic institutions
|
|
£1275+VAT
|
Those working for charities, patient groups or in full-time education
|
|
£1275+VAT |
|
- VAT, if applicable, is charged at the rate of 20%
- The registration fee does not include accommodation
- Refreshments, lunch and evening meal are included in the registration fee
Related courses:
MSc Module 5: Regulatory Control of Clinical Operations
Next steps
Module 4: Regulatory Strategy for a New Active Substance: Nonclinical Developmen
Webinar: CMC
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions