This webinar will give you a good understanding on the scale problem of fake drugs and how the European Medicines Agency and other Regulatory Agencies are now tackling this with the help of the industry via the new Directive.
Why you should Attend
To understand the reasons for "The Falsified Medicines Directive" and the purpose of the FMD.
- How big is the problem?
- What percentage of medicines are falsified?
- Is it more of a problem in developing countries?
- What does the industry have to do?
- What are the acts and security features?How do companies need to comply with the FMD
Areas Covered in the Session
- The definition and scale of falsified medicines
- The European Directive
- The Acts
- Industry and pharmacy requirements to safeguard patients
Who Will Benefit
- Supply Chain
- Healthcare Professionals Working in the Industry
- Hospitals and Pharmacy practices
- Pharmaceutical Wholesalers
- Regulatory professionals in Pharma/Biotech organizations
Yogesh Krishan is a Chartered Chemist, a member of the Royal Society of Chemistry, a member of the Royal Pharmaceutical Society of Great Britain, and he is a member of the Research Quality Association (RQA). He is also a member of the European Union Qualified Person Society. He is registered as a Qualified Person under the Permanent Provisions of the European Directives and is authorised to release Investigational and Commercial medicinal products.
Yogesh's career in the pharma industry spans for more than 30 years and he has operated his own UK limited company - Cypress Quality Consultancy (CQC) Ltd for the past 9.5 years.
CQC Ltd provides Regulatory Compliance support and Quality Assurance education to bio-pharmaceutical clients mainly on the European Regulated Practices. Yogesh also can provide EU QP batch certification and remediation support for a company getting into serious non-compliance via a warning letter following a Regulatory Agency inspection or have had its licenced suspended.
Yogesh has lived and worked in Canada USA, UK, Switzerland and The Netherlands. He has a comprehensive understanding of the USA & EU regulations, quality standards and the expected requirements for the manufacturing, testing and the certification of both sterile and non-sterile medicinal products.
Qualified as a lead GxP auditor, Yogesh has played key roles, including principal lead for hosting Regulatory Agency Inspections for several companies. These inspections were highly successful for the company that Yogesh represented.To date, Yogesh has conducted ca 25 national and international audits of 3rd party manufacturing organisations, quality control laboratories and API suppliers.
He is a signatory on a number of QP Declarations of EU GMP that have been QP certified. Yogesh has been an active participant on the European Qualified Person Group on Falsified Medicines since 2013.