One day  Hot Topic Seminar on:

Falsified Medicines - How can we prevent it?
Gain a broader knowledge of:
• The fight against falsified medicines from a company perspective as well as authority
• Corporate responsibility
• Preventive methods/actions

April 20, 2012, 08.30 – 17.00

At Lersoe Parkallé 101, 2100 Copenhagen, Denmark

Overview:
Falsified medicinal products are a $700 billion industry world-wide. Falsified medicines can kill, cause serious damage to patients, or raise money for other criminal activities. Prevention of falsified medicines is of high importance in order to protect public health and ensuring patient safety.
The purpose of this seminar is to strengthen the awareness regarding the fight against falsified medicines.
The seminar provides a brief overlook on how various companies’ deals with the issue in a legal perspective, as well as using various preventive methods/actions.
What are the corporate responsibilities, and who in the company has it?

It also gives an introduction to what customs do to prevent falsified medicines in crossing the boarders, and how companies can work together with customs.
You will get a status on the new Directive adopted by the EU Commission in February 2011- which safety and control measures does the EMA see in the future distribution chain and how will the Directive protect patients and consumers in the EU region? Last but not least, how does EFPIA recommend implementation of measures like serialization, 2D coding and tamper evidence?

Download program

Seminar Chairs:
• Mette Schou-Hanssen, Regulatory Affairs Manager, Baxter A/S, Denmark
• Thomas Kirkbak, Attorney-at-law, Head of department, Corporate Trademarks & Anti-counterfeit, H. Lundbeck A/S, Denmark
 

Speakers:
•  Thomas Kirkbak, Attorney-at-law, Head of department, Corporate Trademarks & Anti-counterfeit, H. Lundbeck A/S, Denmark
•  Trine Dancygier Kofoed, Head of Division, SKATs Task Force Counterfeiting, SKAT, Denmark
•  Kim Helleberg Madsen, Head of Section, Danish Medicines Agency, Chair of WGEO at the HMA, Denmark &
•  Nimo Ahmed, Head of Intelligence, Medicines and Healtcare products Regulatory Agency (MHRA), UK
• Toon Digneffe, Government Affairs and Public Policy, Director European Affairs, Baxter, Belgium
• Peter Mardov-Egvang, Head of Department, Labelling Design & Development, Novo Nordisk A/S, Denmark

09.00 – 09.15 Welcome and intro to today
Medicademy and Seminar Chairs

09.15 -10.00 Falsified Medicines from a Company Perspective
Where do we see the biggest threats?
- which countries, API, packaging material, finished product, original, parallel import, generics, distributors etc. - and what is Lundbeck doing to handle the risk?
Thomas Kirkbak, Attorney-at-law, Head of department, Corporate Trademarks & Anti-counterfeit, H. Lundbeck A/S, Denmark

10.00 – 10.15 Break

10.15 – 11.45 Falsified Medicines from a Customs Authority Perspective
How do Danish customs authorities prevent falsified medicines products in
Crossing the border to Denmark and how do they identify falsified
medicines?
Trine Dancygier Kofoed, Head of Division, SKATs Task Force Counterfeiting, SKAT, Denmark

11.45 – 12.45 Lunch 

12.45 – 13.45 Falsified Medicines from an Authority Perspective
Which safety and control measures does the EMA see in the distribution
chain to protect patients in the future? How is the work coordinated with
national competent authorities?
Kim Helleberg Madsen, Head of Section, Danish Medicines Agency, Chair of WGEO at the HMA, Denmark &
Nimo Ahmed, Head of Intelligence, Medicines and Healtcare products Regulatory Agency (MHRA), UK

13.45 – 14.00 Break

14.00 – 15.15 Falsified Medicines from a Policy Perspective 
Which legislative actions are proposed by the European Commission and how can it be addressed and used by a company: barcoding, serialisation, safety-features etc.
Toon Digneffe, Government Affairs and Public Policy, Director European Affairs, Baxter, Belgium

15.15 – 15.30 Break
 
15.30 – 16.30 Falsified Medicines in the Organization
Who in the company has the responsibility for preventing falsified medicines? How and where are the different steps initiated and implemented? How can we use it internal and external? What are the consequences on the choice we take?
Peter Mardov-Egvang, Head of Department, Labelling Design & Development, Novo Nordisk A/S, Denmark
 
16.30 – 17.00 Wrap up and Panel Discussion
 Seminar Chairs and All

Target Audience:
The seminar is open for anyone interested in gaining a broader knowledge regarding falsified medicines or working with falsified medicines/counterfeit. E.g. people organised in Packaging & Labelling, Brand Protection, Distribution/Logistics, Anti-counterfeiting Operations, Regulatory Affairs, and Quality Assurance.