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Analytical tools for Characterization of Biotechnology Products and Processes (link) 

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 315

Regulatory Aspects of Biosimilar 'Generic' Drugs

Understand and Implement recent FDA and updated EMA Guidances

Recorded, available with all reference material at any time

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Currently about 76% of prescribed medicines in the US are generic drugs. The reason is a significant price advantage versus innovator drugs. On the other hand innovator biological products have been on the market since long time, e.g., Insulin since 1982 and many of them are running out of patent. For example, it is estimated that US$64 Billion global biological sales will be off-patent by 2015. Despite of high demand currently US FDA has not approved "generic" versions or "Biosimilars" because of lack of adequate legislation. This is changing. Regulations and guidelines have been released in the USA and many other countries and the industry is working hard  to understand and implement the requirements. However, regulations and guidelines are different between different countries and "biosimilars" have new requirements when compared to small molecule based generics , e.g., the conduct of preclinical and clinical studies. So the industry has many questions.

Key Questions related to Biosimilar  are:

  • Why are biosimilar products much more difficult than 'generic' drugs
  • What are the regulations in the US and Europe?
  • What are the regulatory requirements in other countries: Asia, Latin America?
  • How to select the reference product?
  • In which countries are preclinical and clinical tests a 'must'?
  • Under which circumstances do FDA and EMA not require clinical testing?
  • How many preclinical and clinical tests are required by FDA?
  • How many subjects should be tested?
  • Can safety and efficiency of the biosimilar product be better than the reference product?
  • Which meetings with the FDA are Fee-free?
  • What are the criteria for the type and number of Pre/clinical tests?
  • What analytical instruments do we need for structural and functional analyses?
  • What type of studies do we need to demonstrate similarity?
  • How to define release specifications and acceptance criteria?
  • When can we expect an update of the FDA 'biosimilar' guidance documents

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present background information and overview and will give practical recommendations. After the seminar, an extensive list of reference material like SOPs, checklists, case studies, templates and examples will help immediate and cost effective planning for implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet..

During the interactive presentation you learn about:

  • The importance generic drugs for public healthcare
  • The importance of biosimilar products for public healthcare
  • Issues with 'generic' versions of biologics
  • Regulatory situation in Europe
  • Regulatory situation in the United States
  • Regulatory situation in other countries (e.g., Japan, China, India, Brazil, others)
  • Selecting the reference product
  • Justifying and documenting the degree of 'similarity'
  • The need for preclinical and clinical testing: how much, how to document
  • Analysis techniques for structural and functional analysis
  • Regulatory pathway for selling biosimilars to the United States
  • Regulatory pathway for selling similar biological products to Europe
  • Recommendations for implementation

And for easy and instant implementation:
download 10+ documents from special seminar website

  • PowerPoint Presentation
  • ICH Q6B: Test Procedures and Acceptance Criteria for Biotechnological/biological Products
  • 70-page primer: Compliance for Biopharmaceutical Laboratories
  • Checklist: Compliance for Biopharmaceutical Laboratories
  • Reference Paper: Analytical tools for Characterization of Biotechnology Products and Processes (link)
  • Reference Paper: Biosimilar Development - The Race to Market Continues (link)
  • Reference Paper: Looking at the Recent FDA Biosimilar guidelines (link)
  • EMA Procedural advice for users of the centralized procedure for similar biological medicinal products applications
  • WHO Guidelines on Evaluation of similar bio-therapeutic Products (SPCs) link
  •  FDA Presentation 2012: Biosimilar Biological products
  • EMA Guideline on similar Biological Medicinal Products (2005) 
  • EMA Guideline on Similar Biological Medicinal Products (draft, 2013)
  • FDA draft guidance: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • FDA draft guidance: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Who should attend?

  • Biochemist and Biologists working in biopharmaceutical laboratories
  • Documentation professionals
  • QA managers and personnel working for 'bio'pharmaceutical companies
  • Analysts and lab managers
  • Human resources (HR) managers and staff
  • Training professionals
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,