Implementing Argus Safety Japan in the Japan Affiliate Office of a Global Life Science Company

Kc (Keisuke) Katsuyama

Senior Director Japan Practice

November Research Group

SummaryA quick look into the presentation

NRG findings of best practices on how to manage change when working with cross continental teams

Challenges that need to address for a successful implementation of a single database

Benefits from operating under a single system

Reasons and risks of a project delay (from our experience), and how to prevent it from happening

NRG findings of best practices on how to manage change when working with cross continental teams

Challenges that need to address for a successful implementation of a single database

Benefits from operating under a single system

Reasons and risks of a project delay (from our experience), and how to prevent it from happening

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• As November Research Group has encountered within our projects, there are several differences between Japan and the US on the working culture. Among the cultural differences, here are some list of items to be considered to make your project go little more smoothly.

1. Speed vs Consistency

2. Responsibility and roles (Individual vs group)

3. Risk taking method

4. Face to face vs Remote communications

5. Signs to be picked up from the audience

Points to Know Prior to Working With Cross Cultural Team

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• Speed vs Consistency

• Responsibility and roles (Individual vs group)

US Japan

US based company’s decision making is quick. Higher authorizer provides good leeway for subordinates so that they can make decision quickly.

Decision making in stages. Very cautious and conservative so often slower than the US. (number of meetings and documentation process to minimize error)

US Japan

Roles are very individualized.Contribution of individual is important as linked to company goals.

Entire group need to succeed otherwise individual contribution has no meaning.

Points to Know Prior to Working With Cross Cultural Team (Cont’d)

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• Risk taking method

• Face to face vs Remote communications

US Japan

Yes we can attitude even though 50-70% probabilities. After accepted, people try to achieve as close to 100%.

Agreement is very careful, even likely to achieve 100%, still hard to say “YES”. Must make sure it can achieve 100%.

US Japan

Contacting clients by email and phone seems to be natural in conducting business relationship.

Typically meetings each other face to face. Important to conduct business relationship by knowing that individual.

Points to Know Prior to Working With Cross Cultural Team (Cont’d)

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• Signs to be picked up from the audience

US Japan

Every individual can speak without consulting others. Meeting is held because of purpose to understand or clarify things.

Understanding is often unspoken words. Meeting suppose to go as it was already written. Often requires printout of the slides before the meeting.

Points to Know Prior to Working With Cross Cultural Team (Cont’d)

NRG findings of best practices on how to manage change when working with cross continental teams

Challenges that need to address for a successful implementation of a single database

Benefits from operating under a single system

Reasons and risks of a project delay (from our experience), and how to prevent it from happening

9

Key Points to Be Addressed for Single Database

• Japan Day 0

• Use of Medical Representatives

• Reporting in Japanese (MedDRA-J/J-Drug)– For foreign reports, narrative can be in English (however, this varies based on

company policy)

• Reporting on active ingredient

• Foreign Safety Measure Report/Research Report

• Re-examination Report / Evaluation Report

• Support for J-Items (Including E2B Import of zip file)

• PMDA connectivity testing

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• Will Japan Receipt Date be used?

• What site has final decision on seriousness and causality?

• Can Japan perform non-Japan listedness assessment?

• Will there be central Medical Review?

• Case lock points and unlock points for Japan

Considerations for Workflow

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• What name to use for Trade Name (J) of foreign licenses?– Brand Name / Generic Name

• Add ‘MR’ as Reporter Type and use as ‘Correspondence Contact’– Pre-load MR information into Argus (Code List: Reporter Information)

– Cross-reference with Institutions (Code List: Institution)

• Version challenges on the feature limitation and enhancement– Especially from ver. 6.x to 7.x

Other Considerations

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(Note *Not as a compliance limitation or regulation limitation)

• Ad-Hoc reports don’t support Japanese– Case Data Analysis can be useful for J.10 / EPPV report

• No link between WHO-DRUG and J-DRUG

• Many fields are dependent on server time and do not adjust properly– Case Form date

– Japan Receipt Date/Follow-up Receipt Date on PMDA tab

• Out of box Institution study report is not available – PMDA Regulation is supported as a green book

• Doesn’t fully support a separate Japan Workflow

• Doesn’t fully accommodate reporting on active ingredient

Argus J Limitations

NRG findings of best practices on how to manage change when working with cross continental teams

Challenges that need to address for a successful implementation of a single database

Benefits from operating under a single system

Reasons and risks of a project delay (from our experience), and how to prevent it from happening

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Benefits from Operating Under a Single System

Argus Safety / Argus J Single Global Database

Japan / Global Separated Database

Quality Data is always consistent in global level Large sized effort is required to keep/track the consistency

Case Consistency All cases are registered in one database. No discrepancies since no duplicated cases are in the DB

Many discrepancies between duplicated cases (only reportable cases and/or investigational cases might be exchanged)

Case Processing Once a case is entered in one site, it will be available for assessment and reporting in other sites simultaneously

Double case data entry

Data check is necessary on each site

Implementation Load

Single system implementation and single validation (single web server & database server)

Multiple system implementation and multiple validation. System connection for multiple systems

Running Cost No duplication Duplicated

Governance Globally harmonized operation Large dependency on the local operation

Data Processing All data is registered in the sophisticated single database structure, and the case data analysis is easy

Global level data analysis is very difficult because all cases are duplicated and speeded in multiple systems

NRG findings of best practices on how to manage change when working with cross continental teams

The challenges that need to address for a successful implementation of a single database

Benefits from operating under a single system

Reasons and risks of a project delay (from our experience), and how to prevent it from happening

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Company A– additional new features to be added during the implementation

– Budget change due to company merger

– Resource change or scope change

– Regular PV tasks in addition to system implementation work

– Out of scope items discussion

– Workflow agreement with global and Japan

– Legal issue between Japan entity and global HQ (Contract issue with dictionary – J Drug, MedDRA J, etc.)

Company B– Japan PV team does not speak any English (Double meeting is needed to re-

ensure the understanding)

– Minimal training on the user side to understand the concept of features

– Massive amount of products and it is not easy to change product configuration once it is complete (more prior discussion is recommended)

Some of the Lessons Learned from Real Projects

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Some Points to Minimize Project Delay

• Final decisions should be made prior to configuration

• Configuration of Argus in English should occur prior to any configuration in Argus-J to avoid the need for multiple translation iterations

• For translation of case data, a discussion on the timing of translation and case review by different hub(s) is critical for the following:

– Determining how to set-up workflow to accommodate the full case processing timeframe

– Determining when the report needs to be submitted in multiple countries.

• Configure the needed items prior to entering company specific information (Manufacture, List of reporters, etc.)

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Speaker Bio: KC (Keisuke) Katsuyama

Kc Katsuyama is Senior Director of Japan Practice at November Research Group, a professional services company focused on the implementation and support of pharmacovigilance systems. KC is responsible to oversee implementation and development projects with a Japanese product/component, and be a mentor and supervisor to members of Japanese-speaking team. He also provide our client with subject matter expertise in Argus Safety Japan.

Prior to joining November research Group, he was employed in Argus, Argus J, Aris J, and AERS developed companies with areas of Pre-sales consulting, Product Management, Consulting Support. Companies including Oracle, Relsys, and Aris Global.

KC has been focused on the pharmacovigilance business for over 11 years, with back ground role of Director, SME, Product Manager, and Managing QA in the Safety area leading global pharmacovigilance systems. This focus has provided him with a broad understanding of industry best practices and trends including Japan.