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CME Information - Module 1

HARDWARE AND SOFTWARE

The Biosimilar e-Learning Modules, which have been developed using HTML5 technologies, are accessible by using following browsers:

Laptop/Desktop Version

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Chrome
latest (version 48)

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Win 7

Yes

Yes

Yes

Yes

Yes

Win 8.1

  

Yes

Yes

Yes

 -

Yes 

Mac 10.7x

 

 

 

-

Yes

 

Mac 10.8x

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Yes

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Certain activities may require additional software to view multimedia, presentations, or printable versions of the content. These activities will be marked as such and links will be provided to the required software. That software may include: Adobe Flash Player, Adobe Acrobat Reader, Microsoft PowerPoint, and Windows Media Player.

ACCREDITATION STATEMENT

This activity has been planned and implemented in accordance with the essential areas and criteria of the Union Européenne des Médecins Spécialistes (UEMS) and Elsevier. It is accredited by the UEMS-European Accreditation Council for continuing medical education (EACCME) for physicians and specialist nurses.

CREDIT DESIGNATION STATEMENT

The UEMS-EACCME designates this educational activity for a maximum of 1.0 (1 Credit). Physicians should only claim credit commensurate with the extent of their participation in the activity.

DISCLOSURES AND CONFLICTS OF INTEREST

It is the policy of the UEMS-EACCME to require the disclosure of anyone who is in a position to control the content of an educational activity. All relevant financial relationships with any commercial interests and/or manufacturers must be disclosed to participants at the beginning of each activity. The faculty of this e-CME activity discloses the following:

Faculty member and physician taking responsibility for content

 

Manufacturer

 

Relationship

Prof. Juan V. Esplugues,
MD, PhD

 

Gilead Sciences

Abbvie, AstraZeneca, Pfizer

 

Grant/Research Support

Speaker’s Bureau

Independent Reviewer

 

 

 

 

Dr. Shahzada Amir, MD, PhD, MSc

 

 

 

Nothing to disclose

CONFLICT OF INTEREST STATEMENT

Elsevier has obtained the above signed faculty disclosures and has submitted these to the UEMS-EACCME to implement any process to resolve conflicts of interest for this CME activity. In order to help ensure that content of this course is objective, independent, fairly balanced, and aligned with the interest of the public.

UNAPPROVED/OFF-LABEL USE DISCLOSURE

The UEMS-EACCME requires CME faculty to disclose to the participants:

  • If products or procedures being discussed in a course are off-label, unlabelled, experimental, and/or investigational
  • Whether any limitations on the information that is presented, such as data that are preliminary or that represent on going research, interim analyses, and/or unsupported opinion.
  • That medical advisors, authors, speakers and/or moderators disclose when a product is not approved or not approved for the use under discussion.

INTENDED AUDIENCE

This activity has been developed for rheumatologists, gastroenterologists, and dermatologists. Due diligence and care have been taken when preparing module content to reflect the internationally recognized WHO, FDA, EMA terminologies for biosimilars. Furthermore, the module contents were drawn from a number of other countries worldwide, and the literature cited within the modules includes both European and global datasets, thus reflecting an international perspective on biosimilars. The content uses terminology fully consistent with the relevant peer-reviewed literature, and no country-specific brand names are used. It is therefore considered appropriate for an international audience.

PROGRAMME GOALS

Having completed this e-learning course and its accompanying self-assessment questions, the learner should have gained an increased understanding of:

  • The scientific differences between generics and biosimilars
  • The scientific differences between biosimilars and originator biologic medicines, including aspects such as immunogenecity
  • The complexities involved in biosimilar manufacturing
  • How different kinds of changes can affect biosimilar safety and efficacy
  • The steps involved in biosimilar production

EDUCATIONAL OBJECTIVES

The educational needs will be achieved by systemically addressing the need for communication through:

  1. Raising awareness of biosimilars, to support physicians in recognising the practical implications, such as efficacy, safety, immunogenicity.
  2. Assessing the competency of the learner through a post-test evaluation after completion of the course.
  3. Assessing the quality of the course by the learners through a post-course evaluation to be completed by the learner.

CME CREDIT INFORMATION

Release Date: 11 July 2016
Expiration Date: 11 July 2018
Accreditation: 1 hour

FINANCIAL SUPPORT

Disclosure of Financial Relationships:
Elsevier hereby discloses that the Biosimilar e-Learning Modules and Resource Center is sponsored by Abbvie B.V.

Statement of Purpose:
The Activity is for scientific and educational purposes only and will not promote Abbvie’s products, directly or indirectly and is not being given in exchange for any explicit or implicit agreement to purchase, prescribe, recommend, influence, or provide favourable formulary status for any of Abbvie’s products. The website is based upon a budget proposal provided to Abbvie by Elsevier reflecting a good faith estimate of the actual cost of the educational or scientific Activity to be funded pursuant to this Letter of Agreement. The amount has not been determined in a manner that takes into account the volume or value of referrals or business, if any, generated between Abbvie and Elsevier or any of their respective officers, directors, employees, agents, affiliates, parents, or subsidiaries.

Control of Content:
Elsevier is responsible for control of content and selection of medical advisors, authors, presenters, and moderators (if any). Abbvie will not “script,” target points for emphasis or control in any way the planning, content, author/speaker selection, or execution of any Activity that is funded.

Objectivity & Balance:
The Activity will be independent, non-promotional, and free from commercial influence or bias. If Abbvie’s products are mentioned in the course of this Activity, Elsevier will make every effort to ensure that data regarding Abbvie’s products (and competing products) are objectively selected and presented, with favourable and unfavourable information and balanced discussion of prevailing information on the product(s) and/or alternate treatments. The title of the Activity will fairly and accurately represent the scope of the presentation. The Activity will present discussion of multiple treatment options, and will not focus on a single product, except when options are so limited as to preclude meaningful discussion. Elsevier will ensure, to the extent possible, disclosure of limitations of data, e.g. ongoing research, interim analyses, preliminary data, or unsupported opinion.

USER PRIVACY AND CONFIDENTIALITY STATEMENT

Elsevier, being the developer and provider of this activity, respects and confirms the privacy and confidentiality of the Learner, and confirms that any information provided by the Learner will only be utilized for the specific purposes of completing the material.

RELEVANT ETHICAL, MEDICO-LEGAL, AND LEGAL REQUIREMENTS

Elsevier agrees to abide by all relevant standards including: (a) the governing accrediting body standards; (b) Union of European Medical Specialist guidelines; (c) any locally relevant Pharmaceutical Code; and (f) all other obligations under applicable mandatory legislation.

The course will be provided to the Learner, subject to Elsevier’s online Privacy Policy and its online general Terms and Conditions.

The disclaimer below shall be included in the Terms and Conditions which specifically relates to medical or health services information:

“If the Content contained on this site contains medical or health sciences information, it is intended for professional use within the medical field. No suggested test or procedure should be carried out unless, in the reader's judgment, its risk is justified. Because of rapid advances in the medical sciences, we recommend that the independent verification of diagnoses and drug dosages should be made. Discussions, views, and recommendations as to medical procedures, products, choice of drugs, and drug dosages are the responsibility of the authors.”

HELP – ASSISTANCE

The course has a built in user help button to guide the learner through all relevant areas of the course.

CONTACT DETAILS FOR TECHNICAL OR OTHER ASSISTANCE

The Biosimilar e-Learning Modules have provided the email address of: elsevierpharmasolutions@elsevier.com

The learner/user may address all issues regarding the course and or website via this address which will be monitored 24 hours daily and responded to within 48–72 hours of the inquiry.

TO PRINT YOUR CERTIFICATE

The learner/user will be prompted and guided to the Biosimilar e-Learning Modules for course evaluation feedback and a printable certificate.

DESCRIPTION OF PROVIDER

Elsevier is committed to making genuine contributions to the science and health communities.

We are proud to be part of the science and health communities and to participate in the advancement of these fields. By delivering world-class information and innovative tools to researchers, students, educators, and practitioners worldwide, we help them become increasingly more productive in their work. We make substantial investments of capital and resources, which are required to manage the complex processes and innovations that serve the needs of the global science and health communities.

NAMES AND QUALIFICATIONS OF INDIVIDUALS RESPONSIBLE FOR PREPARATION OF CONTENT

Medical Advisor:
Juan Vicente Esplugues Mota, MD, PhD

Biography:
Juan V. Esplugues is Professor of Pharmacology at the University of Valencia and Clinical Pharmacologist at Dr. Peset University Hospital, both in Valencia, Spain. He leads the Digestive and Inflammatory Diseases Research Unit, a large multidisciplinary research group that carries out pharmacological research related to the digestive tract and inflammation.

Professor Esplugues is Vice President of the Scientific Committee of the Foundation for the Promotion of Health and Biomedical Research in the Valencian Community (FISABIO) and leads a research group at the Centro de Investigación Biomédica en Red (CIBERehd), a Spanish national network of groups researching hepatic and digestive diseases. Previously, he was the Scientific Coordinator of the Fundación Centro Nacional de Investigaciones Cardiovasculares (CNIC), a government-funded cardiovascular research institute.

Professor Esplugues has published numerous original articles and reviews in prestigious international journals including Gastroenterology, Hepatology, Proceedings of the National Academy of Sciences of the United States of America (PNAS), Immunity, Circulation, Circulation Research, Trends in Pharmacological Sciences, and British Journal of Pharmacology. He has been the Principal Investigator of over 30 national and international research projects.

Disclosure
The physician taking responsibility for the content and the medical advisor were responsible for the medical content and received editorial/writing support in the preparation of this course. This course has been sponsored by Abbvie B.V. The medical advisor was fully responsible for contents and editorial decisions for this course.

Acknowledgment
Dr. Shahzada Amir, MD, PhD, MSc
Dr. Megan Breuer, PhD, provided scientific writing/editorial support for this course