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e Conferences from CDG...

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Every problem is an opportunity.
e-Conferences are 90-minute slices of current content that identify typical clinical or regulatory problems and offer serious solutions. In each event we pick an issue of current concern, describe the issue (regulation, expectation, obstacle) and then offer strategies, case studies, or solutions to help you use the problem to get better work result.

A one-hour PowerPoint presentation by an expert in the field is followed by 30 minutes of Q&A, so you have ample opportunity to get the personal attention you need.

Upcoming e-Conferences
Working Effectively with CROs
Changes in Japanese Shonin Regulations

Past e-Conferences
 Click here
 

Schedule:
May 6, 2009 at 11:00 am Central

Fee: $424 per computer connection

Agenda:
Lecture - 60 minutes
Q&A - 30 minutes

How it works:
Once your order is processed, you will receive an email with a receipt for the credit card transaction from our office. You will also receive an automatically generated email with an invitation for you to register in the course. Please register, provide your email address and create a password. Once your invitation is accepted, you will receive an automatically generated email with the link to join the session.

Quantity:

Working Effectively with CROs

Common Mistakes with CROs
Over and over again sponsors make the same mistake when choosing a Contract Research Organization. They base the choice on cost rather than reputation, capability, demonstrated knowledge, contribution to the industry, and a match in size, philosophy, and attitude. Then, after having chosen poorly, they fail to manage the CRO or stay in close contact.

Learning Objective
You will learn the regulatory, legal and financial pitfalls in the use of a CRO for a research project and how to protect your organization from such pitfalls.

Step by Step
Steven Schurr, Esq. will walk you through the process of hiring a CRO for medical device research. He will cover:
[x] The risks involved in utilizing a CRO versus hiring in-house employees to perform the tasks.
[x] The best ways for a sponsor to solicit and evaluate potential CRO vendors.
[x] Once the sponsor chooses a CRO vendor, how to structure the budget and contract.
[x] How to monitor and evaluate the performance of the CRO during the project.
[x] What happens if the project needs to be expanded beyond its original scope after the original contract is finalized.
[x] What the sponsor should do if they choose to terminate the contract with the CRO while the project is ongoing.

Case Studies
Mr. Schurr will use case studies of precarious situations to demonstrate what can go wrong, explanations of what caused the situations, and recommendations on how to avoid them.

Are You A CRO?
For the CROs in the audience, Mr. Schurr will have a few words about choosing a client. Vendors should go through a selection process too, as was vividly demonstrated in the recent GAO sting operation against independent IRBs. You should ask questions like:
[x] Is the client honest?
[x] Do they want an ethical research study with data that have proven integrity?
[x] Can they pay you?

Results
After this e-conference you will have an increased ability to choose and manage a CRO.

CROs will have a better ability to select a responsible client.

You will receive:
[x] An expert speaker.
[x] PowerPoint slides.
[x] Chance for QnA.
[x] CEUs and certificate of attendance.

Who should attend:
[x] Clinical research professionals who participate in the CRO selection process.
[x] Managers who sign-off on CRO selection.
[x] CROs who want to improve their presentation.
[x] Executives who are planning the future of their company.

Presenter
Steven C. Schurr, Esq. worked extensively as a regulatory affairs and clinical research professional and consultant for 12 years within both the medical device and pharmaceutical industries prior to becoming an attorney. In 1994, Mr. Schurr graduated from Loyola University of Chicago School of Law and became a member of the Illinois State bar.  In 1995, Mr. Schurr became a member of the Indiana State bar.  Mr. Schurr currently concentrates his legal practice, based out of Chicago, in health care law.  Mr. Schurr is an advocate for patient’s rights, the disabled, the elderly and various health care organizations.  He also is involved in federal disability law, food, drug and device law, medicare, medicaid, medical ethics and federal patient privacy issues.  He can be reached at scschurr@steveschurr.com.
   

Schedule:
May 20, 2009 at 11:00 am Central

Fee: $420 per computer connection

Agenda:
Lecture - 60 minutes
Q&A - 30 minutes

How it works:
Once your order is processed, you will receive an email with a receipt for the credit card transaction from our office. You will also receive an automatically generated email with an invitation for you to register in the course. Please register, provide your email address and create a password. Once your invitation is accepted, you will receive an automatically generated email with the link to join the session.

Quantity:

Changes in Japanese Shonin Regulations

Japanese Reforms for Device Approval (Shonin)
Your company is bound to want to sell its devices in Japan eventually. The figure below, even though for drugs, shows Japan to be the second largest healthcare market in the world. With an aging population, it is one of the most desirable markets for medical devices.  


http://www.morganlewis.com/pubs/Overview_Pharma_device_reg.pdf

But for foreign manufacturers, complying with Japan's Pharmaceutical Affairs Law (PAL) can be challenging. Few English language documents have been issued by the Ministry of Health, Labor and Welfare (MHLW) and its division, the Pharmaceutical and Medical Devices Agency (PMDA). Language barriers and a complex registration process make Japan one of the most difficult and time consuming markets for medical device manufacturers to enter.

Concerned that Japan’s reputation as a difficult market might cause it to fall behind, the Japanese government made significant revisions to PAL in 2005, but many people feel the changes have not been enough. Shonin regulations, which control the process of approval to market medical devices in Japan, have also been recently reformed.

Depending on the level of novelty, medical devices shall be classified into three levels: new medical devices, improved medical devices, and "me-too" medical devices (devices with a predicate technology already on the market), with each evaluated by a specialized team. The new evaluation system will simplify the application forms (including partial changes) and may shorten the evaluation process for minor modifications, such as changing a raw material in a device that does not affect the function or efficacy of the device.

Once part of a previous review process in Japan, the three-track evaluation system was discontinued when the new regulatory rules were implemented in 2005. Taking into account current criticism, MHLW/ PMDA decided to revive the previous review method, which will be rolled out in a step-by-step fashion beginning in April.

Learning Objective
In this e-conference you will learn about the new submission categories, overviews of each Shonin category, and the role of clinical trial data for each of them.

Making a New Submission Strategy
 Two questions:

As a manufacturer of a Class II medical device with two facilities (a headquarters and a manufacturing plant) what has to be done, and what is the best way to enter the Japanese market?
[1] Register the manufacturing facility (Nintei)?
[2] Nominate a Market Authorization Holder (MAH) or A-MAH (Appointed MAH) in Japan?
[2] Obtain Shonin (device approval) or Certification (device certification)?

As a manufacturer of a Class III medical device, what is your best strategy for entering the Japanese market?
[1] Nominate a MAH or A-MAH in Japan who has a license to market your product?
[2] Register the manufacturing facility(Nintei)?
[3] Obtain Shonin pre-market approval?
[4] Determine who can sell the devices in the Japanese market?

In this e-conference we’ll discuss how you decide which strategy is right for you.

Because of the time difference between Chicago and Tokyo, this e-conference will be pre-recorded. The audio will be broadcast by VoIP on your computer speakers.

You will have a chance to submit questions during the broadcast, which will be answered in writing by Ms. Matsunaga. When you register you may submit questions before the e-conference if you like.

You will receive
[x] Spreadsheet of application categories and requirements.
[x] Glossary of Japanese regulatory terms.
[x] PowerPoint slides
[x] An expert speaker
[x] Chance for QnA
[x] CEUs and certificate of attendance.

Who should attend
[x] Regulatory professionals who are involved in Japanese submissions.
[x] Clinical research professionals who design clinical trials for Japan.
[x] Device manufacturers planning to export to Japan.
[x] Marketing professionals who plan to market in Japan.
[x] Executives who are planning the future of their company.

Presenter
Nobuko Matsunaga is Chief Regulatory Officer at Japan Medical Device Consulting. Before founding Japan MDC with Kunihiko Mitsuda, Ms. Matsunaga worked in the area of regulatory affairs in the medical device field. At Japan MDC, she has worked on product registration for various types of medical devices.

In addition to the daily work of regulatory consulting, she also contributes to improving the regulatory environment in Japan as a member of the regulatory sub-committee of the EBC (The European Business Council in Japan). She can be reached at nobuko.m@j-mdc.com or www.j-mdc.com.

 

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