Title: Counterfeit Medicine
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2- Instructor Profile
- Angela Bazigos, is the CEO of
Touchstone Technologies Silicon Valley, Inc.
"Knowledge is Power". She has 35 years of
experience in the Life sciences industry spanning
GLP, GCP, GMP, Medical Devices 21 CFR 11 and
has a patent aimed at speeding up Software
Compliance.Ms. Bazigos is a Past President of
PRCSQA, a member of the SQA CVIC, ASQ, DIA and
RAPS. She works closely with the FDA on behalf of
her clients. She consults to Life Science
Investment Groups as well as to Pharma / Biotech
/ Medical Device companies on compliance matters,
including strategy, submissions, quality
assurance and remediation following action by the
FDA.More recently, Ms. Bazigos co-authored
Computerized Systems in Clinical Research /
Current Data Quality and Data Integrity Concepts
with FDA, DIA and Academia.
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3- Description
- Counterfeit medicine is a fake
medicine. It may be contaminated or contain the
wrong or no active ingredient. They could have
the right active ingredient but at the wrong
dose. Counterfeit drugs are illegal and are
frequently harmful to consumer health up to and
including death of a patient. - Counterfeit drugs are a 75
Billion / year business with phenomenal profits.
Counterfeit medicine may be either a fake drug or
a fake ingredient that finds its way into the
manufacture of a legitimate medicine.
Counterfeit
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4- Why Should you be Attending?
- Counterfeiting has significant
economic consequences. In reality, it "hijacks"
the brand and infringes the patent and trademark
rights of legitimate pharmaceutical
manufacturers. Additionally, counterfeiters take
full advantage of the fact that someone else paid
the upfront money for research and development
expenses all counterfeiters have to do is to
copy the appearance of the product.Even if a
drug is manufactured in the United States or by
an international reputable firm, many of the raw
ingredients of a drug are often imported from
countries that have loose regulatory oversight.
This was the case with Heparin a few years ago,
where a counterfeit ingredient in the drug caused
the death of 80 people.Â
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5- Objectives of the Presentation
- The objectives of the presentation are
- What is a counterfeit medicine / ingredient
- How pervasive is the problem
- What risks are associated with counterfeit
- medicines / ingredients
- What are the economic consequences of
- counterfeiting
- How do counterfeit medicines / ingredients
- enter the United States and our supply chain
- Who profits from counterfeit medicine/
ingredients - How to purchase medicines / ingredients to
- avoid counterfeits
- How can you tell if you receive a counterfeit
- What can you do to address the problem
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6- Who can be Benefited?
- Doctors
- Nurses
- Regulatory Affairs
- Quality Assurance
- Manufacturing
- Regulatory Authority Inspectors
- Consumers
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7- Live Session - How it works?
- Username and Password will be sent to you 24
hours prior to the webinar - Presentation handouts in pdf formate will be
mailed to you - Login to the session using the username and
password provided to you - Get answer to your queries through interactive
QA sessions via chat - Get certification of attendance.
- Recorded Session - How it works?
- A link will be provided to you upon purchase of
the recorded session - Please click on the link to access the session
- Presentation handouts in pdf formate will be
mailed to you - Get certification of attendance.
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
8www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com