Peer to peer practical guidance on remote inspections and audits

Minutes and communication of F2F meetings ( v1.2 )

Minutes

The BioPhorum facilitator(s) will capture the key discussions, proposals and decisions in an Event Report. This report will act as the Minutes of the meeting and will

• detail the objectives, attendees and agenda
• include hyperlinks to all the materials shared in the event and an executive summary. All materials shared via hyperlinks will be in pdfs to lock down the contents in their presented form.
• Contain photos of the presenters and the team to help participants put names to faces after the event. If you do not want to be photographed please let the facilitator know.

Our aim is to circulate the Event Report in draft form within six working days of the meeting, to all the participants.  A final draft will then be made available to all other workstream reps and Phorum Leaders (L2s).

Circulation to guests will be at the discretion of the facilitator(s) and team.

Photos of presentations must only be taken with the express agreement of their author.

Communication

Often discussions in meetings are exploratory and involve testing ideas, solutions and approaches.

We ask that all representatives in the meeting and dialling in respect the unformed state of discussions and agree not to comment on the discussions publicly on social media or report on the discussions on open public channels, during the meeting and until the final draft of the Event Report has been circulated and any messaging and communications strategy of the team has been agreed.

This is not a bar to representatives communicating about the meeting with peers, colleagues and stakeholders in their own organisation, this is very much encouraged

Supplier interactions ( 3.0 )

The BioPhorum Operations Group (BioPhorum) facilitates a cross industry collaboration process for Biopharmaceutical developers and manufacturers with the aim of accelerating the rate at which the biopharma industry attains a mature and lean state benefitting patients and stakeholders alike. Collaboration modes include best practice sharing, benchmarking, joint-solution development to common challenges, definition of standards requirements and formation of collective perspectives to mutual opportunities and regulatory guidelines.

Biopharmaceutical developers and manufacturers recognize the legally enforceable duties they have including the responsibility to control the quality of materials from their suppliers. From time to time BioPhorum-facilitated collaboration requires, and benefits from, supplier interaction.

Suppliers are providers of supply chain materials such as chemicals, glass, components, excipients, and media. They are also providers of process equipment such as single use systems, engineering parts and consumables. BioPhorum-facilitated supplier interactions may involve: harmonizing manufacturer requirements and communicating these to suppliers; seeking feedback on proposed standards; gaining opinions and ideas related to business process improvement; use of problem solving tools; and gaining support for new ways of working.

The ultimate goal of the BioPhorum collaboration is to strengthen competition, assure product quality and protect patient supply.

The purpose of this document is to set out the principles and policies that BioPhorum follows to ensure that BioPhorum-facilitated supplier interactions are conducted in the correct and appropriate way to meet all legal and business compliance requirements.

Underlying principles and policies

Competition Laws: All supplier interactions will comply with anti trust and competition laws and have regard to BioPhorum’s anti-trust compliance statement

Member responsibilities: Individual biopharma companies are responsible for defining their requirements of suppliers.

Innovation and commercial interests: All supplier interactions will recognise and respect the need for suppliers to innovate and pursue their own commercial interests.

Intellectual Property: All supplier interactions will respect suppliers’ intellectual property rights.

Confidentiality / Non Disclosure: All supplier interactions will take into account, respect and encourage compliance with confidentiality and non-disclosure agreements.

Equal Treatment: All suppliers will be treated equally

Communication: These principles, policies and procedures will be communicated to BioPhorum members and suppliers whenever supplier interactions are planned or are taking place.

BioPhorum responsibilities

• It is the responsibility of BioPhorum Directors to ensure that these principles and policies are upheld and procedures are in place to support them.
• BioPhorum will educate and train its staff so they understand and follow these principles and policies and are able to communicate them when needed.
• BioPhorum documentation will reference or directly include relevant parts of the Supplier Interaction Policy.
• BioPhorum will establish and maintain records to demonstrate compliance with these principles and policies.

Code of Conduct – BioPhorum information sharing ( v4.0 )

Introduction

The BioPhorum Operations Group (BioPhorum) is a cross industry collaboration with the aim of sharing best practice in the area of Operational Excellence.

Participation in BioPhorum is restricted to authorized member company representatives as described in the Principles of Membership Agreement.

While sharing information is central to the process of this collaboration, it is important to understand what information is appropriate to share. Our companies have a great deal of confidential information and intellectual property that should not be shared within BioPhorum.

This document seeks to guide the reader so that the individuals and companies involved follow the correct code of conduct and problems are avoided.

It is the clear and stated intention of BioPhorum that the Group and its activities are conducted at all times in full compliance with relevant competition/anti-trust rules.

Responsibilities

It is the responsibility of every person who participates in a BioPhorum event or sharing activity to make sure they are aware of what information is appropriate to share. Furthermore, all participants are responsible for vetting any information to be shared via their company’s public disclosure review processes and that all information shared is free of any “Confidential” stamps or markings.

The key contact (L2) for each member company should ensure confidentiality and that IP issues are highlighted to their colleagues and all applicable company policies regarding external collaboration and public disclosure are adhered to.

The BioPhorum facilitators are responsible for reminding all participants of their obligations with respect to information sharing.

Participants’ contact details

Every person who participates in the Biophorum collaboration will have access to the business contact details of other participants. These details should only be used for making contact with other participants in matters that relate directly to their work in Biophorum.

Use of these contact details by participants in the following circumstances is prohibited:

• Compilation of mailing lists and advertising or marketing of any kind
• Creating a database of contact details in any circumstances
• Recruitment and job advertising

Participants who are unsure as to whether their use of contact information is acceptable or not should refer to their Biophorum representative.

Sharing information

The following list is representative of the types of disclosures commonly allowed by corporate policies. BioPhorum participants should review their company policies to ensure they are in compliance prior to any disclosures. Information in the following areas is typically allowed:

• Operational excellence best practice models
• Management approaches and philosophies
• Organizing and planning ways of working
• Non-product or process specific generic operating procedures
• Information in the public domain
• Information provided by suppliers which would ordinarily be shared with customers
• Non-product or process specific generic engineering or technical information relating to process equipment
• General learning and ‘context’ conclusions from QA and Regulatory activity

Sharing information from the following areas is typically prohibited by corporate policies

• Product related information
• Product related process data which constitutes intellectual property
• Specific audit or regulatory inspection findings or observations
• Product specific analytical methods
• Specific cost numbers where a market advantage may result or a supplier might be disadvantaged
• Information that is marked as confidential by the member company or a supplier
• Price information of any type
• Proprietary information including intellectual property and patented processes and equipment.

BioPhorum event participants should direct all questions regarding information disclosure to their L2 BioPhorum representatives or corporate legal departments.

Anti-trust compliance statement ( v4.0 )

It is the clear policy of BioPhorum that BioPhorum and its members will comply with all relevant anti-trust laws in all relevant jurisdictions.

All BioPhorum meetings and activities shall be conducted to strictly abide by all applicable antitrust laws. Meetings attended by BioPhorum members are not to be used to discuss prices, promotions, refusals to deal, boycotts, terms and conditions of sale, market assignments, confidential business plans or other subjects that could restrain competition.

Anti-trust violations may be alleged on the basis of the mere appearance of unlawful activity. For example, discussion of a sensitive topic, such as price, followed by parallel action by those involved or present at the discussion, may be sufficient to infer price-fixing activity and thus lead to investigations by the relevant authorities.

Criminal prosecution by federal or state authorities is a very real possibility for violations of the antitrust laws. Imprisonment, fines or treble damages may ensue.

BioPhorum, its members and guests must conduct themselves in a manner that avoids even the perception or slightest suspicion that antitrust laws are being violated. Whenever uncertainty exists as to the legality of conduct, obtain legal advice. If, during any meeting, you are uncomfortable with or questions arise regarding the direction of a discussion, stop the discussion, excuse yourself and then promptly consult with counsel.

The antitrust laws do not prohibit all meetings and discussions between competitors, especially when the purpose is to strengthen competition and improve the working and efficiency of the marketplace. It is in this spirit that the BioPhorum conducts its meetings and conferences.

Privacy Notice

This is the privacy notice of BioPhorum Operations Group Ltd. In this document, “we”, “our”, or “us” refer to BioPhorum Operations Group Ltd.

We are company number 06794795 registered in UK.

Our registered office is at 5 Westbrook Court, 2 Sharrow Vale Road, Sheffield, S11 8YZ.

Introduction

BioPhorum Operations Group Ltd facilitates a global industry collaboration between member companies to accelerate progress within the industry. BioPhorum’s collaboration is built upon principles of openness, trusted relationships and respect for individuals, to encourage greater competitiveness and innovation.

This privacy notice aims to inform you about how we collect and process any information that we collect from you, or that you provide to us. It covers information that could identify you (“personal information”) and information that could not. In the context of the law and this notice, “process” means collect, store, transfer, use or otherwise act on information. It tells you about your privacy rights and how the law protects you.

We are committed to protecting your privacy and the confidentiality of your personal information. Our policy is not just an exercise in complying with the law, but a continuation of our respect for you and your personal information.

We undertake to preserve the confidentiality of all information you provide to us, and hope that you reciprocate.

Our policy complies with the Data Protection Act 2018 (Act) accordingly incorporating the EU General Data Protection Regulation (GDPR).

The law requires us to tell you about your rights and our obligations to you with regards to the processing and control of your personal data. We do this now, by requesting that you read the information provided at http://www.knowyourprivacyrights.org

Except as set out below, we do not share, or sell, or disclose to a third party, any information collected through our website.

1. Data we process

If you interact with us, we may collect personal data from you through the medium of the interaction.  For example, we will collect your name, phone number, email address and/or correspondence address.

We will collect personal data from you when you interact with us, for example if you register for an event, or use our public or member websites.

Sometimes we will obtain your personal data from others, including in particular your employer. For example, your employer may provide us with your personal data when nominating you for a team or to attend an event.

We may collect, use, store and transfer different kinds of personal data about you. We have collated these into groups as follows:

• Your identity includes information such as first name, last name, title and other identifiers that you may have provided at some time.
• Your contact information includes information such as business address, email address, telephone numbers, your preferences in receiving newsletter updates and any other information you (or your employer) have given to us for the purpose of communication or meeting.
• Technical data includes your internet protocol (IP) address, browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform and other technology on the devices you use to access this website. We use this information to help us administer, protect and improve our services, analyse usage and improve users’ experiences.

We may aggregate anonymous data such as statistical or demographic data for any purpose. Anonymous data is data that does not identify you as an individual. Aggregated data may be derived from your personal data but is not considered personal information in law because it does not reveal your identity.

For example, we may aggregate profile data to assess interest in a product or service.

However, if we combine or connect aggregated data with your personal information so that it can identify you in any way, we treat the combined data as personal information and it will be used in accordance with this privacy notice.

2. Special personal information

We do not collect any special personal information about you.

3. If you do not provide personal information we need

Where we need to collect personal data by law, or under the terms of a contract we have with you, or to download our materials through our website and you fail to provide that data when requested, we may not be able to perform that contract or comply with your request to download the materials. In that case, we may have to stop providing a service/materials to you. If so, we will notify you of this at the time.

The bases on which we process information about you

The law requires us to determine under which of six defined bases we process different categories of your personal information, and to notify you of the basis for each category.

If a basis on which we process your personal information is no longer relevant, then we shall immediately stop processing your data.

If the basis changes then if required by law we shall notify you of the change and of any new basis under which we have determined that we can continue to process your information.

4. Information we process with your consent

As part of BioPhorum’s core goal of accelerating industry progress, non-member communication with the wider industry takes place via BioPhorum’s public website and other media including emails. In order to build effective communication networks, monitor document downloads and generate follow-up interaction, including a newsletter and updates, some personal information is collected via consent.

Anonymized and aggregated document download information is shared with member organizations, however your personal information is not shared. Your email addresses are retained indefinitely for the purposes of record keeping.

If you consent to us sending you news updates about our products and services we will process your personal data in order to send you news updates and to make sure that any news updates that we send you are relevant to you.

You can withdraw your consent for us to send you news updates at any time by contacting privacy@biophorum.com, or by unsubscribing using the link at the bottom of the news update.

When you visit our website you may be asked to consent to the placement of cookies on your device. You do not have to accept our cookies but if you do not your experience may not be as fulfilling as it would be otherwise.

Through certain actions when otherwise there is no contractual relationship between us, such as when you browse our website or ask us to provide you more information about our business, including job opportunities, or products and services, you provide your consent to us to process information that may be personal information.

We continue to process your information on this basis until you withdraw your consent or it can be reasonably assumed that your consent no longer exists.

5. Information we process because we have a contractual obligation with you or your organization

We will collect and process biographical personal data from you, namely your name, telephone number, address, email address and IP address in order to provide our products and services to you and perform our contract with you.

We will use this data to ensure that we know who you are and that we comply with our obligations under the contract. More specifically we will use this data to:

• manage and administer your membership account or other products and services that we provide to you
• establish your eligibility for products and services and supply you with those products and services
• process your registrations for participation in events that we run
• contact you by post, phone, text message, email, social media, or fax using our online website or other means
• manage and respond to a complaint or appeal
• keep proper records.

6. Information we process for the purposes of legitimate interests

We may process information on the basis that there is a legitimate interest, either to you or to us, of doing so.

Where we process your information on this basis, we do so after having given careful consideration to:

• whether the same objective could be achieved through other means
• whether processing (or not processing) might cause you harm
• whether you would expect us to process your data, and whether you would, in the round, consider it reasonable to do so.

For example, we may process your data on this basis for the purposes of:

• record-keeping for the proper and necessary administration of our business
• responding to unsolicited communication from you to which we believe you would expect a response
• data you submit to us relating to an enquiry about our products and services
• data about how you use our website and services for the purpose of analyzing the use of the website and services
• data relating to your account (including your name and email address) for the purpose of operating our websites, providing our services, ensuring the security of our website and services, and maintaining our backups of your data bases
• data included in your personal profile on our website for the purpose of enabling and monitoring your use of our website and services
• protecting and asserting the legal rights of any party
• insuring against or obtaining professional advice that is required to manage business risk
• inviting you to relevant industry events that we organise
• for marketing purposes (see below)
• protecting your interests where we believe we have a duty to do so.

7. Information we process because we have a legal obligation

Sometimes, we must process your information in order to comply with a statutory obligation.

For example, we may be required to give information to legal authorities if they so request or if they have the proper authorization such as a search warrant or court order.

This may include your personal information.

Specific uses of information you provide to us

8. Information provided on the understanding that it will be shared with a third party

Our website allows you to post information with a view to that information being read, copied, downloaded, or used by other people.

Examples include:

• posting a message on our forum
• tagging an image
• clicking on an icon next to another visitor’s message to convey your agreement, disagreement or thanks.

In posting personal information, it is up to you to satisfy yourself about the privacy level of every person who might use it.

We do not specifically use this information except to allow it to be displayed or shared.

We do store it, and we reserve a right to use it in the future in any way we decide.

Once your information enters the public domain, we have no control over what any individual third party may do with it. We accept no responsibility for their actions at any time.

Provided your request is reasonable and there is no legal basis for us to retain it, then at our discretion we may agree to your request to delete personal information that you have posted. You can make a request by contacting us at privacy@biophorum.com

9. Complaints regarding content on our website

Our website is a publishing medium. Anyone may register and then publish information about himself, herself or some other person.

We attempt to moderate user generated content, but we are not always able to do so as soon as that content is published.

If you complain about any of the content on our website, we shall investigate your complaint.

If we feel it is justified or if we believe the law requires us to do so, we shall remove the content while we investigate.

Free speech is a fundamental right, so we have to make a judgment as to whose right will be obstructed: yours, or that of the person who posted the content that offends you.

If we think your complaint is vexatious or without any basis, we shall not correspond with you about it.

10. Job application and employment

If you send us information in connection with a job application, we may keep it indefinitely in case we decide to contact you at a later date.

If we employ you, we collect information about you and your work from time to time throughout the period of your employment. This information will be used only for purposes directly relevant to your employment. After your employment has ended, we will keep your file for six years before destroying or deleting it.

11. Communicating with us

When you contact us, whether by telephone, through our website or by e-mail, we collect the data you have given to us in order to reply with the information you need.

We record your request and our reply in order to increase the efficiency of our business.

We keep personally identifiable information associated with your message, such as your name and email address so as to be able to track our communications with you to provide a high quality service.

12. Complaining

When we receive a complaint, we record all the information you have given to us.

We use that information to resolve your complaint.

We may also compile statistics showing information obtained from this source to assess the level of service we provide, but not in a way that could identify you or any other person.

13. Marketing

We strive to provide you with choices regarding certain personal data uses, particularly around marketing and advertising.

Promotional offers from us

We may use information gathered (including personal data) to form a view on what we think you may want or need, or what may be of interest to you. This is how we decide which products, services and offers may be relevant for you (we call this marketing).

You may receive marketing communications from us if you have requested information from us, downloaded any materials from us, or if you provided us with your details when you have interacted with, or had involvement with BioPhorum, (for instance if you have registered for a promotion/event) and, we have a legitimate interest in communicating with you. In each case, you have the right to opt out of receiving that marketing (see below).

Use of information we collect through automated systems when you visit our website

14. Cookies

Cookies are small text files that are placed on your computer’s hard drive by your web browser when you visit any website. They allow information gathered on one web page to be stored until it is needed for use on another, allowing a website to provide you with a personalized experience and the website owner with statistics about how you use the website so that it can be improved.

Some cookies may last for a defined period of time, such as one day or until you close your browser. Others last indefinitely.

Your web browser should allow you to delete any you choose. It should also allow you to prevent or limit their use.

Our website uses cookies. They are placed by software that operates on our servers, and by software operated by third parties whose services we use.

If you choose not to use cookies or you prevent their use through your browser settings, you will not be able to use all the functionality of our website.

We use cookies in the following ways:

• to track how you use our website
• to record whether you have seen specific messages we display on our website
• to keep you signed in to our site
• to record your answers to surveys and questionnaires on our site while you complete them
• to record the conversation thread during a live chat with our support team.

15. Personal identifiers from your browsing activity

Requests by your web browser to our servers for web pages and other content on our website are recorded.

We record information such as your geographical location, your Internet service provider and your IP address. We also record information about the software you are using to browse our website, such as the type of computer or device and the screen resolution.

We use this information in aggregate to assess the popularity of the webpages on our website and how we perform in providing content to you.

If combined with other information we know about you from previous visits, the data possibly could be used to identify you personally, even if you are not signed in to our website.

Disclosure and sharing of your information

16. Data may be processed outside the European Union

Our website is hosted in the UK.

We may also use outsourced services in countries outside the European Union from time to time in other aspects of our business.

Accordingly, data obtained within the UK or any other country could be processed outside the European Union.

For example, some of our third-party providers are based in the United States of America or Canada.

We use at least one of the following safeguards with respect to data transferred outside the European Union:

• Where we use certain service providers, we may use specific contracts approved by the European Commission which give personal data the same protection it has in Europe. For further details, see European Commission: Model contracts for the transfer of personal data to third countries

• We will only transfer your personal data to countries that have been deemed to provide an adequate level of protection for personal data by the European Commission. For further details, see European Commission: Adequacy of the protection of personal data in non-EU countries. Where we use providers based in the US, we may transfer data to them if they are part of the Privacy Shield which requires them to provide similar protection to personal data shared between the Europe and the US. For further details, see European Commission: EU-US Privacy Shield.

Control over your own information

17. Your duty to inform us of changes

It is important that the personal data we hold about you is accurate and current. Please keep us informed if your personal data changes.

18. Access to your personal information

To obtain a copy of any information that is not provided on our website you should contact us to make that request.

After receiving the request, we will tell you when we expect to provide you with the information, and whether we require any fee for providing it to you.

19. Removal of your information

If you wish us to remove personally identifiable information from our website, you should contact us to make your request.

This may limit the service we can provide to you.

20. Verification of your information

When we receive any request to access, edit or delete personal identifiable information we shall first take reasonable steps to verify your identity before granting you access or otherwise taking any action. This is important to safeguard your information.

21. Opting Out

You can ask us to stop sending you news updates and/or marketing messages at any time by contacting privacy@biophorum.com, or (where available) by unsubscribing using the link at the bottom of the news update and/or marketing messages.

Where you opt out of receiving these marketing messages, this will not apply to personal data provided to us as a result of our services or other transactions.

Other matters

22. Use of site by children

We do not sell products or provide services for purchase by children, nor do we market to children.

23. Encryption of data sent between us

We use Secure Sockets Layer (SSL) certificates to verify our identity to your browser and to encrypt any data you give us.

Whenever information is transferred between us, you can check that it is done so using SSL by looking for a closed padlock symbol or other trust mark in your browser’s URL bar or toolbar.

24. Data Security

We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. In addition, we limit access to your personal data to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal data on our instruction and they are subject to a duty of confidentiality.

We have put in place procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.

25. How you can complain

If you are not happy with our privacy policy or if you have any complaint then you should tell us.

If a dispute is not settled then we hope you will agree to attempt to resolve it by engaging in good faith with us in a process of mediation or arbitration.

If you are dissatisfied with how we process your personal information, you have a right to lodge a complaint with the Information Commissioner’s Office (ICO). This can be done at https://ico.org.uk/make-a-complaint/. We would, however, appreciate the opportunity to talk to you about your concern before you approach the ICO.

26. Retention period for personal data

Except as otherwise mentioned in this privacy notice, we keep your personal information only for as long as required by us:

• to provide you with the services you have requested
• to comply with other law, including for the period demanded by our tax authorities
• to support a claim or defence in court.

27. Compliance with the law

Our privacy policy has been compiled to comply with the law of England and Wales. If you think it fails to satisfy the law of your jurisdiction, we should like to hear from you.

However, ultimately it is your choice as to whether you wish to use our website.

28. Review of this privacy policy

We may update this privacy notice from time to time as necessary. The terms that apply to you are those posted here on our website on the day you use our website. We advise you to print a copy for your records.

If you have a question regarding our privacy policy, please contact us.

Your legal rights

You have the right to:

Request access to your personal data (commonly known as a “data subject access request”). This enables you to receive a copy of the personal data we hold about you and to check that we are lawfully processing it.

Request correction of the personal data that we hold about you. This enables you to have any incomplete or inaccurate data we hold about you corrected, though we may need to verify the accuracy of the new data you provide to us.

Request erasure of your personal data. This enables you to ask us to delete or remove personal data where there is no good reason for us continuing to process it. You also have the right to ask us to delete or remove your personal data where you have successfully exercized your right to object to processing (see below), where we may have processed your information unlawfully or where we are required to erase your personal data to comply with local law. Note, however, that we may not always be able to comply with your request of erasure for specific legal reasons which will be notified to you, if applicable, at the time of your request.

Object to processing of your personal data where we are relying on a legitimate interest (or those of a third party) and there is something about your particular situation which makes you want to object to processing on this ground as you feel it impacts on your fundamental rights and freedoms. You also have the right to object where we are processing your personal data for direct marketing purposes. In some cases, we may demonstrate that we have compelling legitimate grounds to process your information which override your rights and freedoms.

Request restriction of processing of your personal data. This enables you to ask us to suspend the processing of your personal data in the following scenarios: (a) if you want us to establish the data’s accuracy; (b) where our use of the data is unlawful but you do not want us to erase it; (c) where you need us to hold the data even if we no longer require it as you need it to establish, exercise or defend legal claims; or (d) you have objected to our use of your data but we need to verify whether we have overriding legitimate grounds to use it.

Request the transfer of your personal data to you or to a third party. We will provide to you, or a third party you have chosen, your personal data in a structured, commonly used, machine-readable format. Note that this right only applies to automated information which you initially provided consent for us to use or where we used the information to perform a contract with you.

Withdraw consent at any time where we are relying on consent to process your personal data. However, this will not affect the lawfulness of any processing carried out before you withdraw your consent. If you withdraw your consent, we may not be able to provide certain products or services to you. We will advise you if this is the case at the time you withdraw your consent.