|
Training
In any pharmaceutical company it is the responsibility of the Regulatory Affairs department to ensure that your product has approved Marketing Authorisations for each product in each territory on the target date. Due to the complexity of the EU system for Marketing Authorisations applications, it can take years of practice to get your staff to a level of competency to achieve this goal every time.
Ivowen Limited can provide your company with specialised Regulatory Affairs training, tailored to your specific needs. We specialise in generic pharmaceutical medicinal products and their registration and this involves an in-depth understanding of the commercial and marketing requirements of generic pharmaceutical companies.
Regulatory Affairs training is not just for your Regulatory Affairs team! Each company is a compact unit made up of interdependent departments. The success of any company rests on knowing its target markets and getting a quality product to these markets on time in a cost effective manner.
Each department in a company is dependent on each other department to provide the expertise and experience necessary to achieve the company's goals.
However, this cannot be done without the input, data and support of the following departments and people:
- Patents
- Research and Development
- Analytical
- Quality Assurance
- Quality Control
- Stability
- Production
- Logistics
- Sales and Marketing
- Administration
Ivowen Limited can provide Regulatory Affairs Overview Training to all interested parties. This will provide an insight into what Regulatory Affairs do, why they do it, how they do it and what they need from other departments to make it work. Also included is comprehensive, specialised training in all htmlects of the EU legislation and in the MRP/DCP/CTD system for registering generic drugs in the EU, which is our speciality.
Training includes:
- Full text notes including suggested wording for certain sections of the dossier
- Case studies tailored to your level of knowledge
- All relevant and current guidelines for each section
For a sample of a training module please contact us.
Training topics covered include:
| Introduction to Regulatory Affairs |
- Introduction to the EU - commission, parliament, legislation (soft and hard law), etc
- Directive
2001/83(82)/EC, as amended and Regulation 726/2004 – the legal basis for marketing authorisations in the EU
- Marketing authorisation procedures in the EU
- Essential similarity
- Accession - Marketing Opportunities in the expanding EU market
- ICH harmonisation - registering your product in the EU, US and Japan
|
| |
|
| General Regulatory issues |
- Guidelines to be followed during the R&D phase
- Sourcing drug substances and excipients
- The manufacturing chain and implications for the QP and other departments, including contract manufacture.
- Release of product onto the EU market from within and from outside the EEA.
- Sales and Marketing - how to get the products you want in all markets on time
|
| |
|
| Regulatory Strategy |
|
| |
|
| Paediatric Investigation Plans (PIPs) and Paediatric Use Marketing Authorisations (PUMAs) |
- The Paediatric Regulation, Commission Regulation EC 1901/2006, as amended.
- Preparation of PIPs, PIP waivers and PIP deferrals
- Documentation requirements
- EU procedures for PIP applications
- Information on PUMAs
|
| Common Technical Document |
- What is it?
- Advantages
- Current and future situation
- eCTD
|
| |
|
Module 1 |
- What is required for generics
- SmPC harmonisation
- PILs and labelling/User testing
- Local requirements
|
|
|
Module 2
|
- What is required for generics
- Quality Overall Summary
- Clinical Overview
- Non-clinical Overview
|
| |
|
Module 3 |
- What is required for generics
- Drug Substance
- Drug Master File,
- Certificate of Suitability
- Pharmaceutical Development and Validation
- Analytical Development and Validation
- Method of Manufacture
- Stability
- Specifications
- Excipients
- Packaging
|
| |
|
Module 4
|
- What is required for generics
|
| |
|
Module 5
|
- What is required for generics
- Bioequivalence and bioavailability
- Clinical trials directive - implications for generics
- Good Clinical Practice - responsibilities of Sponsor and CRO
- Selection of Clinical Research Organisation
- Biostudy design
|
| |
|
Variations |
- Commission Regulation EC 1234/2008
- Type IA , IB, II
- Documentation requirements
- Notification vs. variation applications
|
For individual training plans tailored to your company's specific needs, please contact us. |
