1. Customer Engagement Programs (CEP) and the Line of Sight (LOS) System
Training for Pfizer Vendor and Agency Partners
January, 2017

2. About CEPs: Definition
CEPs are programs sponsored by BUs and Divisions, at the global, regional or country levels, in which there is the potential for two-way communication between Pfizer or a vendor acting on Pfizer’s behalf and customers (e.g. patients, HCPs) through which Adverse Events and /or other reportable safety information may become evident
Pfizer
Health Care Professional
Patient /Other customers or
2-way
communication
Customer Engagement Programs
Digital Media
- Mobile Apps
- Interactive Internet Sites
- Social Medial
Interactive Webcast
Patient Support Programs
Call Centers
Disease Awareness / Screening
Pfizer Sponsored
Philanthropic Program
Market Research
or Texting Programs
Direct Mail with
Business Response Cards
NOT Customer Engagement Programs
Sales calls
HCP / Consultancy Engagements
Non-Interventional Studies
Pfizer Medical Information
Clinical Trials
Philanthropic Donation Programs
Compassionate Use / Expanded Access
Secondary Market Research
Advertising & Promotional Materials
Exhibits, Congress Participation, Symposia
Advisory Boards
Webcasts (one-way communications)
Speaker Training Programs
IIRs (CT-25)

3. What Will Darwin Deliver? CEP in a Box
We Need to strike the Right Risk / Benefit Balance in the CEPs We Run… A B
…Ensure Adherence
to the Process, As Well as to Local Laws
and Regulations…
…And Submit All Reportable Information to Safety in Complete and Timely Manner C
CEP
CEP in a Box
Approval Process
Reporting and Analytics
A packaged set of solutions implemented to enhance CEP processes and management
Governance
CEP Support Structure
Training
New Tools
Darwin Program’s Objective Statement is…
1. We need strike the right risk / benefit balance in the CEPs we run…
2. Ensure adherence to the process, as well as to local laws and regulations
3. And submit all reportable information to Safety in a complete and timely manner
To meet these objectives the Darwin Program will implement “CEP in a Box”- a set of solutions that includes:
A streamlined approval process
Local CEP governance which includes participation from Safety, Medical, Commercial, Legal, Regulatory, and Technology representatives participating in the approval of CEPs. This governance model includes additional local stakeholders to bring their expertise into the evaluation and management of CEPs.
Enhanced CEP Training to inform of roles and responsibilities
Vendor Oversight support to give Program Owners more insight into vendor operations
Reporting and Analytics to give insight into CEP Performance
A Local, Regional, and Global support structure for Program Owners
New tools to make CEPs easier to manage
Through implementing the “CEP in a Box” solutions, Darwin seeks to meet the objectives.
Vendor Oversight
Communications

4. What you will learn from this training module
What is the LOS system?
Step by step process explaining your interaction with LOS
Gaining Access to LOS
Assigning personnel to a project
Creating and submitting activity logs
The importance of the LOS summary page
Troubleshooting / Q&A

5. What is the LOS system?

6. LOS…
This system was designed to provide oversight of all customer engagement programs (CEPs) to ensure compliance with Pfizer corporate policy
System defaults to English but can be changed to 8 other languages via the “Preferred Language” button on each page
Is a user-friendly platform that replaces all of the paper-based compliance processes currently in use:
Excel spreadsheets of daily activities
Certification of program start and end dates
Certification of AE training form
Is a validated system, which means it can be utilized during an audit or inspection
Is ‘read only’ for Pfizer colleagues –vendors are the only persons who can actually input information into LOS

7. LOS is a platform that is connected to 2 other systems – CEP Inventory and PPLS
Program Owner
Project Name
Project Description
BU / Stakeholder
Country of Conduct
Planned Start Date
Actual Start Date
Planned End Date
Actual End Date
Vendor Contact Info
And others….
CEP Inventory contains a historical record of all customer engagement programs. Pfizer Program Owner is responsible for inputting projects into the inventory
PPLS is the “external” version of P2L – an online training system
List of certified vendor personnel
LOS is updated by CEP and PPLS every 24 hours (at a minimum)

8. Vendor personnel working on a Pfizer CEP can fall into one of two categories
Vendor Project Manager
Usually the project leader for the project
VPM’s name/ must be entered into the CEP inventory by the Pfizer Program Owner
Possibly to have more than one vendor project manager, especially for multi-country programs
Be sure to include all names and s in your proposal in order for the Pfizer Program Owner to record them in the CEP Inventory
Decides who within their firm (or subcontractors) will support the CEP
All personnel are required to complete the course for CEP Certification
Sends LOS invitations to any personnel or subcontractors who do not have a current CEP Certification or LOS account
All invitees must have a valid, professional address – do not use a personal address
Each person must have a unique address – do not use distribution lists or mail boxes
Assigns fully certified personnel to the CEP in LOS (including themselves)
Vendor Project Personnel
Anyone working on a Pfizer CEP and assigned to that project in LOS

9. The CEP Inventory provides LOS access to the Vendor Project Manager
Under the ‘Vendors’ tab in the CEP Inventory:
Program Owner will upload the vendor contract
Contract is visible to only Pfizer Program Owner program owner and safety
Pfizer Program Owner will indicate that this project is managed through LOS
Pfizer Program Owner will enter the name(s) of the Vendor Project Manager (VPM) and his/her address
VPM will receive invitation from LOS (if Pfizer Program Owner has checked that the program is managed in LOS)
Once the VPM accesses LOS, he/she can add additional employees to the CEP

10. Using LOS
The balance of this presentation will focus on how to incorporate LOS into the conduct of CEPs
Gaining Access to LOS
Inviting personnel to take CEP Certification courses
Creating accounts in PPLS
Creating accounts in LOS
Changing your password
Understanding who has access to LOS
Assigning personnel to a CEP
Adding and deleting personnel from a CEP
Creating and submitting activity logs
The importance of the LOS summary page

11. Gaining Access to LOS
Inviting Personnel to Create Accounts Creating PPLS or P2L Accounts and taking Certification Courses Creating LOS Accounts Setting and changing your Password Logging in and Troubleshooting

12. Getting started Before anyone can access LOS they must have:
Completed the CEP Certification courses in PPLS or P2L
Been invited to create an account in LOS
Only personnel who have completed the CEP Certification courses will show up in LOS as eligible to work on a project
Everyone (Vendor, subcontractors, recruiters) who will be in a position to detect an AE MUST complete the online certification courses in PPLS or P2L AND be added the CEP
Not everyone needs to create an account in LOS
You do not need to have an active account in LOS in order to be added to a CEP
Only those people who will actually be creating activity logs are required to create an account
As long as you complete the CEP Certification courses, your name will appear in LOS and you can be added to a CEP, without having created an account

13. Inviting personnel to LOS and PPLS/P2L
First step in the process is sending an invitation via LOS
This can be done by the vendor project manager or by Pfizer. For firms new to LOS, the initial invitations will come from Pfizer. After that, the vendor PM will be responsible for inviting new colleagues, including subcontractors and recruiters.
The invitation will provide a link to complete the CEP Certification courses in PPLS or P2L and, if necessary, create an account in LOS once training is complete
To send out the invitations, click the ‘Vendor Account Administrator’ button on the top left corner of the dashboard

14. This takes you to the “Vendor Account Administrator” screen
Anyone in your organization who has already been invited to create an account will show up in the box
If others in your organization (including subcontractors, recruiters, etc.) will need access to LOS and/or the safety training, then you need to click the “Invite New Personnel” button.

15. Inviting new personnel
Begin by selecting your organization from the drop down menu
Next, add the s (please do not use personal accounts)
Separate each with a semi-colon (or use separate lines)
It is also fine to cut and paste a long list of addresses

16. Inviting new personnel (continued)
Once you have everyone’s address that you would like to invite, click the “Verify Users” button.

17. Inviting new personnel (continued)
If you have entered a valid address, the system will return a “verification successful” status.
If you’ve made any errors (such as rather than .com) the system will return an error message
If you’ve entered an address of a colleague who has already been invited, the system will alert you to that as well.
If the user will not be reporting in CEPLOS & only needs to complete AE certification, then do NOT check the “Include LOS in ” box
Once the s are verified, click the “Proceed to Invite” button

18. Inviting new personnel (continued)
When you click the “Proceed to Invite” button, the system will show you the following message:
Just click “OK”
Once your personnel receive the invitation, they can go directly into PPLS or P2L to create their accounts and take their training

19. Invitation emails to external vendors
From: Pfizer CEP LOS Sent: Friday, July 1, :03 AM To:
Cc:
Subject: P ACTION REQUIRED - Pfizer CEP Line of Sight Invitation from test user
You have been invited to complete the requirements to use Pfizer’s CEP Line of Sight (CEPLOS) System by test user Action is required by you.
1) You must complete the current version of the required certification in the Pfizer Partner Learning system (PPLS) training system before working on a Pfizer CEP.
Click here to access the Pfizer Partner Learning system (PPLS)
Click on the “Create your own account link” at the PPLS log on page. If the link does not appear on the log on page, please alert
Create your own username & password
Be sure to use in the space your address is requested
Look for confirmation s the next day from CEPLOS Support and the PPLS Admin. Please do not create duplicate accounts while waiting to be approved
The day after receiving the confirmation s, please log into your PPLS account & complete the YRR course titled, “Self-Study Course:2016 Your Reporting Responsibilities Training for Vendors Working on Pfizer Programs (excluding clinical studies)”
2) If you are responsible for maintaining CEP data in the Pfizer CEP Line of Sight (CEPLOS) system on behalf of your organization
Visit using to create an account 24 hours after you have completed both the YRR and LOS trainings
Note that PPLS and CEPLOS are two different Pfizer systems. You have to setup separate accounts in the two systems.
Please contact if you encounter any difficulties! Read this helpful guide for any questions about getting started with CEPLOS as a CEP Vendor. This was auto-generated by the CEPLOS System. Please do not reply to this . Please contact for any support queries.
This invitation will expire in 90 days.
You must always use the exact address that is shown in the invitation .
Once you create your account in PPLS, it generally takes 1-2 days for it to be approved by Pfizer. Once approved, you will be notified by the system and able to access the required training modules.
You must complete the CEP Certification courses before you attempt to create an account in LOS. Please note that it takes 24 hours for PPLS to update LOS with record of your training.

20. PPLS Landing Page
When you click the link in the from LOS, it will bring you to this page
Click on the “Create your own account” link to set up your account in PPLS
Input your address as your username
You will also designate your password
Remember – it takes 24 hours for Pfizer to approve the creation of your account
Something to think about. In the fall, the new AE training will be released that combines the YRR and Supplemental CEP training into one document. Also, it appears as though the LOS training will also be housed in PPLS beginning sometime around April – May time frame. We will need to make reference to this in the training document

21. PPLS will notify you when your account has been approved by Pfizer
The will look similar to the one shown below
Once you get the you can click the link to access PPLS and take the two CEP certification courses
PPLS will also send you an acknowledging completion of those courses

22. Register for the CEP Certification course in PPLS
Click the ‘start’ button.
Click on Start

23. CEP Certification course in PPLS
There is one course that comprises the CEP Certification
 All users must recertify when the certification courses is updated – usually annually, but sometimes more frequently
Once certification has been completed, you will be able to create an account in LOS. Please note it usually takes 24 hours for PPLS or P2L to update LOS.

24. Accessing LOS
Once you’ve completed your CEP Certification in PPLS access the LOS system
This will bring you to the log-in screen
System shows GMT on every screen
Click “Get Support” to submit a help desk ticket
Click the “?” to access LOS Help
At the bottom are links to the privacy policy, terms of use, contact us
Username is your address – the one you used to create your account in PPLS
To create your account, click “I don’t have an account yet” to begin the process

25. Accessing LOS– creating your account
When you click “I Don’t Have an Account Yet”, the following will appear on the login page. Enter your address (which will be your username going forward), the letter/number combination from the captcha and then hit ‘submit’
The system will send you a link via that you will use to access the system and create your password
When you receive the , simply click on the link, enter your username and then select the password you want to use

26. Accessing LOS – resetting your password
If you forget your password, or need to reset your password, click ‘Forgot Password? on the login screen. As with creating a new account, you should enter your address, the letter/number combination from the captcha and hit submit. The system will you a link to LOS that will allow you to reset your password.
Please note that your passwords will expire every 120 days

27. Logging into LOS When you log into LOS for the first time:
The system will present you with a link to download LOS system training material. You will be required to certify that you have reviewed the training material before you can start using the system.

28. Logging into LOS – continued
The system will also present you with the ‘Announcements’ box which will display any new messages from the system.
You can select the ‘Do not show this message again’, and it will not appear each time you login. Any system announcements are also available on the dashboard.

29. Troubleshooting LOS login
If you are unable to logon to the system, LOS will let you know the reason why
The most common reason for inability to access is that you are not assigned to an active CEP
Vendor personnel are only able to access LOS if they are either the Vendor Project Manager for a CEP, or have been assigned to the CEP by the Vendor project manager

30. Navigating the LOS dashboard Adding (Assigning) Personnel to the CEP
Getting Started
Navigating the LOS dashboard Adding (Assigning) Personnel to the CEP

31. Landing page for CEP LOS dashboard
Search functionality: find your Pfizer CEPs, both active and closed
List auto-populates your first 5 active CEPs
Automatically updates with new projects to which you’ve been added
Click on the CEP ID number for details
Access system training by clicking the link

32. Starting a new project
Your first responsibility is to select the frequency with which you will be submitting your activity logs

33. Starting a new project – Determining log frequency
To determine the frequency with which you must submit activity logs, answer all questions in the tool provided

34. Starting a new project – Assign Personnel
Your next step is to assign personnel to the CEP
The Assign Vendor Personnel button is only visible to the Vendor Project Manager(s)
VPMs should assign ALL personnel working on the project to the CEP
Only personnel who will be submitting activity logs need to have an account in LOS
Non-submitting personnel do not need an account in LOS, but must have completed the CEP Certification courses in PPLS

35. Starting a new project – Assign Personnel
Select the box next to the names of personnel to be assigned
Page forward to access all personnel
Personnel whose AE Certification has expired, or will expire in 30 days, cannot be assigned to a project until they re-certify in PPLS or P2L
Send non-complaint personnel a reminder to recertify so they can be added to the project

36. Starting a new project – Assign Personnel
To assign new personnel from your organization
Type the user’s name & save changes
Confirm you want to continue
Verify green box with confirmation message appears

37. Starting a new project – Assign / Remove Personnel
Those assigned to the project are shown at the top of the screen
You can add or remove personnel at any time during the program
To remove personnel
Remove check mark from next to the name in Select column
Save changes
Confirm you want to continue
Verify green box with confirmation message appears
IMPORTANT!
Un-assign from any active projects employees who leave your organization or no longer work on Pfizer projects , then to have the account deactivated.

38. Adding personnel outside your organization
You have the ability to include people outside your organization
This would include, for example, subcontractors
If they are in LOS, but they were added & trained by a different vendor:
If these people are not already in LOS:
Send them an invitation through LOS for the CEP Certification courses in PPLS
Going forward, simply add them to a project in the same way as you would employees of your firm
Type in their address and hit the “Add” button and then the “Save Changes” button. If they are trained and in the system, they will be added to your list

39. Submitting Activity Logs
When to Submit Activity Logs Accessing the Activity Log Page Completing the Activity Log Closing out the project in LOS

40. When to submit an activity log
If your frequency is daily, you are required to submit an activity log to the Program Owner on a daily basis
You are not required to submit activity logs on weekends
Logs for Saturday & Sunday should be submitted on Monday
AE submissions to Drug Safety Unit (DSU) still must be within 24 hours or 3 calendar days, whichever is shorter
If your frequency is weekly, you are required to submit an activity log every Monday
If Monday is a holiday, then you submit the activity log on Tuesday.
If your frequency is monthly you are required to submit an activity on the first business day of each month
If your frequency is ‘as needed’ (qualitative primary market research only), you will submit an activity log covering each day there is two-way interaction with customers
This means that you do not have to complete an activity log on days where you are not conducting interviews or having other contact with customers
The system expects a report on the next date you specify

41. Adding a new activity log
From the Dashboard, click on the CEP ID number
Below the CEP Summary, click ‘Add/Update Activity Log” link
This link is not visible until the vendor project manager has selecting the reporting frequency and assigned personnel to the CEP
Any vendor personnel having an account in LOS and assigned to the CEP can submit an activity log

42. Adding a new activity log
To create the first log, select “Create Activity Log”
To add subsequent reports, select “Update Activity Log”

43. CEP activity log screen

44. Creating an activity log – Country of Conduct
Under “Country of Conduct”, select the country for which you are submitting an activity log
Selecting a country not included in the CEP created by your Pfizer Program Owner yields this error
Submit separate activity logs for each country in which the CEP is being conducted
Begin submissions when two-way communications with customers begins in that country
You can submit the activity log for the country if you are, in fact, conducting programs there
The Pfizer Program Owner will be automatically notified that they need to update the project in the CEP inventory

45. Creating an activity log – CEP Stage
LOS allows two activity logs per country per day to account for recruiting (PMR only) and engaging in two-way dialog with customers in the same country
1 activity log for recruiting and 1 activity log for engagement

46. Creating an activity log – Log Frequency
Enter the date on which the two-way customer interactions took place NOT the date on which you are submitting the log
Your first activity log for a CEP (in each market) is the day two-way communications commenced
This is critical because the date of first activity represents ‘documented evidence’ (for audits and inspections) of the actual start date
The last activity log represents ‘documented evidence’ of the actual date on which two- way communications ended
Example: Your internet survey went live on Wednesday, March 16th. On Thursday, March 17th, you access all of the data from March 16th and review for potential product safety reports. Then, you access LOS and enter the activities. The log’s date should be March 16th - the day the surveys were taken.

47. Creating an activity log – Reason for Late/Updated Log
If the system detects that your activity log is late, then the drop down menu becomes active
LOS does, however, account for weekends, so activity logs for weekend days are not considered late if they are submitted on Monday.
LOS does not account for holidays in any country, so use the general comments field to account for any late report due to a holiday
You must select one of the reasons in the drop down menu, or select the “other” option before you can proceed
You will then be asked to specify why the log was late / updated

48. Creating an activity log – Number of Interactions: non-PMR projects
For non-Market Research projects:
Total number of incoming communication including but not limited to:
Face to Face
Fax
Paper Based Communication (e.g. Mail, BRC)
Phone
Text Message (SMS)
Online Chat (webcast, chatroom, live help)
Online Survey
Internet Site
Social Media
Mobile App / App Store
Remember, this is the number of interactions that took place for the period which you are submitting the activity log. This is not a cumulative number.

49. Creating an activity log – Number of Interactions: Primary Market Research
For primary market research, interactions refer to:
Total number of completed internet, paper or face-to-face surveys
Total number of respondents contacted (where two way communication was established) during recruiting
Note: unanswered s, busy signals, no answer or hang-ups do not count as interactions – they can be ignored. There must be some level of contact established.
Total number of one-on-one interviews completed during the reporting period
Total number participants in focus groups completed during the reporting period.
Remember, this is the number of interactions that took place on the date for which you are submitting the activity log. This is not a cumulative number.
In other words, the sum of all interactions at the end of a project will equal your total sample size.

50. Creating an activity log – Unfinished Surveys/Survey Screen-outs (PMR)
Refers to partially completed surveys that must continue to be monitored daily until the respondent finishes the survey, or the survey is closed to respondents
Example: A physician starts a survey on Sunday, completes half then saves it. On Monday, when the data is reviewed, this physician’s responses would be considered an unfinished interaction. The physician could change answers or mention an adverse event when s/he completes the survey. On Wednesday, the physician returns, completes the survey & submits it. On Thursday, when the data is reviewed, this physician’s responses would now classify as a finished interaction.
Also includes those who completed the screener, but did not qualify for the main questionnaire
Example: Data from an internet study is reviewed on Tuesday for the surveys that were begun/completed on Monday. Thirty five patients attempted the survey but didn’t pass the screening criteria. All 35 would be counted as unfinished interactions.
Enter ‘0’ only if there were no incomplete surveys or screened out respondents.

51. Creating an activity log – Number of Product Safety Reports
Number of Product Safety Reports – indicate the total number of product safety reports that were submitted to Pfizer’s Drug Safety Unit (DSU)
Submit only the number of product safety reports for the period for which you are completing an activity log (daily, weekly, monthly, as needed)
Reminder PSRs must be reported to the DSU within 1 Business day (24 hrs or 3 Calendar days, which ever is shorter)
Product safety reports include: adverse events, “at risk” scenarios—that is, circumstances leading to increased risk for an adverse event (such as exposure during pregnancy, exposure during breastfeeding, medication errors, off label use), product complaints, and medical device complaint reports
If there were no product safety reports submitted to the DSU for that activity period, then enter “0”

52. Creating an activity log – Delayed Product Safety Report
Use if a product safety report is sent to the DSU more than 1 business day or 3 calendar days after discovering the adverse event or other product safety issue
When box is checked, two more areas appear to provide additional information about the late PSRs

53. Creating an activity log – General Comments
LOS provides a ‘general comments’ box to allow you to annotate any activity log
Examples of annotation include:
Number of late product safety reports
Reason why there were no interactions on a particular date
Reason why an activity log was created before one was expected
Track ID number of online surveys you’ve reviewed
Please do not provide any confidential information or product safety reports in the general comments box

54. Creating an activity log – Next CEP Activity Log Actions
Next CEP Activity Log Actions refers to the next day on which you will be accessing LOS to submit an Activity Log
All next activity dates will be prepopulated except “As Needed”
For ‘as needed’ frequency, you must enter the next date that you will access LOS
Example: I am conducting qualitative interviews on Wednesday, March 9th and Tuesday, March 15th. On Thursday, March 10th, I enter LOS and complete an activity log for Wednesday, March 9th interviews and again on Wednesday March 16th for March 15th interviews..
Click the calendar below the ‘Next CEP activity log on YYYY-MM-DD’, and select the date that you will enter LOS and submit the activity log for Tuesday’s activities
LOS will not expect any activity logs on this CEP until Wednesday, March 16th

55. Creating an activity log – Next Activity Log FAQs
What happens if I’ve indicated my next activity log date in LOS for an ‘as needed’ project, and the interviews that were to take place on that day are cancelled?
Simply go into LOS, enter the activity date and enter “0” for complete, incomplete and product safety reports. In the ‘general comments’ space, it would be helpful to type in the fact that the interviews scheduled for that date were cancelled.
What happens if I add interviews that will take place before the next activity log date that I indicated on my last activity log?
On the day the interviews take place (or the next day), access LOS and complete an activity log as you normally would. The system will not prevent you from completing an activity log prior to your ‘next activity log’ day.
You would indicate the ‘next follow-up day’ as the date from your previous activity log

56. Creating an activity log – Submitting the activity log
Once all of your information is complete, hit the ‘submit activity’ button
Creates a record of your activity log
Date/Time stamped (using Greenwich Mean Time)
Person completing the report is identified
Cannot be altered by anyone at Pfizer
If you’ve made mistakes or left out required information, the system will alert you to make the changes. When you have successfully submitted an activity log, you will see the following:

57. Submitting a late activity log
There may be times when you will have to submit an activity log late due to situations beyond your control:
Internet outage
LOS system not available
Holiday
Fill out an activity log in the same way as above. The only addition is that you must provide a reason for the late activity log in the ‘Reason for Late/Updated Log’ box.
And remember to select the appropriate date (e.g., the date on which the two-way customer interactions took place).
Example: If you had 20 calls to a call center January 19th, but the internet was down until January 22nd, and you go into LOS on the 22nd to submit that activity log, the activity log date would be January 19th.

58. Making changes to an existing activity log
To make a change to an activity log that you have already submitted:
From the dashboard select
All of your previously submitted activities are available
In the column marked “select”, choose the activity log that you need to modify. Note that the ‘Update Activity Log’ button does not become active until you select an activity log to update

59. Making changes to an existing activity log
Incorporate changes
Provide reason for change
- LOS will not allow you to submit without providing reason
Country of Conduct, Activity Log date, and Next CEP Activity Log Actions are not editable
Audit trail showing all changes to Activity Logs is saved

60. Closing out your project in LOS
When you submit the last activity log for a program/country, select ‘No further interactions with customers in that market and activity stage Engagement
When you make this selection, LOS will show the following summary. If the CEP is conducted in multiple countries, it will show the summary status for each market

61. Closing out your project in LOS – PMR ONLY
Important - For primary market research projects using recruiters
You must select ‘No further interactions with customers in (country) for both activity stages (engagement and recruitment)
When you submit your activity log for the last day of recruiting, select ‘No further interactions with customers in (country) for the recruiting stage
When you submit your activity log for the last day of two-way communications (e.g., surveys, interviews, etc.), select ‘No further interactions with customers in (country) for the activity stage of engagement

62. Closing out your project in LOS
When LOS detects that you have indicated no further activities for all the countries of conduct and all activity stages, you will see the following:
Click Yes, and then submit the activity if the activity log represents the end of all two-way communications with customers for that CEP

63. Closing out your project in LOS
Even though you’ve indicated that the activity is complete, you will still have the ability to make changes or updates until the project is officially closed by the Pfizer Program Owner in the CEP Inventory
The Pfizer Program Owner will close out the project in CEP no later than 60 days after you submit your final activity log, indicating that activity is complete
If you get close to the 60 day time frame and realize that you need additional time, just contact your Pfizer Program Owner and ask him/her to delay closing the project in the inventory

64. CEP Summary Page
Contains all information that was migrated from the CEP inventory
CEP Exceptions – areas where LOS and CEP Inventory do not match, late activity reports, etc.
Summary of the activities and Product Safety Reports

65. CEP Summary Page (Continued)
All of your activity logs (shown in groups)
Information concerning vendor personnel assigned to the program and the dates of their training
In the event of an audit, this is how you will demonstrate compliance with CEP policy
Everything is exportable to Excel and printable

66. Additional Topics: Navigating in LOS, Alerts, System Issues and Trouble- shooting

67. Navigating in LOS
The four buttons on the dashboard will take you to the areas within LOS
Vendor Account Administrator
CEP summary
Assigning personnel (only visible to Vendor Project Managers)
Submitting or adding to an activity

68. Navigating in LOS
To return to the dashboard from these three areas, simply click “Back to Dashboard” at the top left of your screen
When you are finished, click “Log Out” at the top right of your screen
Clicking the “?” at the top of the page provide detailed information about the specific area you’re on

69. Alerts
The LOS system will send out a variety of alerts to you and to your Pfizer Program Owner:
Daily alerts to Pfizer Program Owner summarizing the activity logs
Alerts to Pfizer Program Owner when reporting has started, an activity log is submitted late, an activity log is submitted for a country not indicated in the CEP inventory and when an activity log is updated
Alerts to Pfizer Program Owner when the project has completed
For the vendors, LOS:
Alerts the vendor when an activity log is past due or training is nearing expiration
Copy of the daily summary of activity logs
All LOS communications go to the Vendor Project Manager

70. If There are Issues With LOS…
Should the LOS system be unavailable during the execution of a CEP, you should immediately revert back to whatever backup methodology Pfizer has in place for that particular communication channel / CEP type
Once the system is accessible, enter all of the activities for the days that the system was down (if applicable)
In the reason for late/update log dialog box, simply indicate that LOS was unavailable between _____ and ______
Capture any vendor personnel changes after the fact, as needed

71. Troubleshooting
If you experience technical problems with PPLS, P2L or LOS:
If you are able to get into the system, click “get support”.
You can report the issue from the ‘get support’ button.
If the system is completely down
If you have process questions you can contact your Pfizer Program Owner or CSS Local Lead

72. Goal: of LOS is to make it easier for Pfizer and our vendor partners to comply With CEP policy
Where LOS has been deployed (Country/BU), it is no longer necessary to:
Send s or other forms of certification of the program’s actual start and end date
Complete the Certification of AE training document for your employees and subcontractors
And, you do not have to keep copies of the CEP Certification certificates
Send excel / copies of Activity Logs
LOS is also a tool that provides external inspectors and internal auditors evidence of compliance with Corporate Policy 902 and 902a.
LOS will continue to improve with enhanced features

73. Important Note
NOTE:
Line of Sight (LOS) is being rolled out globally over the course of and 2017
Until such time as the roll out is complete it is possible you may be working on programs for other BUs or in Countries where LOS has yet to be deployed
In that case you will need to follow all existing required activities and processes for any program that is not being tracked by LOS, For example:
Collecting signed training certificates
Storing signed training certificates for 10 years

74. Questions???