THE ONLY EVENT FOCUSED ON GCP INSPECTION …info.exlevents.com/rs/exlevents/images/C625_final.pdf• Global Compliance • Pharmacovigilance • Clinical Research • Safety and Risk

CLINICAL TRIALS INSPECTION READINESS SUMMIT

23-24 April 2015 • Hilton London Kensington • London, UK

TOP REASONS TO ATTEND:

• Review crucial information and analysis of regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA regulations

• Benchmark the success of clinical trials with relevant metrics for measuring the performance of CROs and trial sites

• Learn strategies to ensure comprehensive clinical trial storyboarding to help inspectors recreate the trial through these vital documents

• Leverage process maps that can be applied to streamline TMF management and the key team members who need to be involved

• Innovate your inspection readiness SOPs with information on risk-based modeling for inspection readiness

EUROPEAN

THE ONLY EVENT FOCUSED ON GCP INSPECTION READINESS IN THE EU!

Improve Inspection Readiness Through Maximizing Document Quality and Accessibility and Enhancing Partnerships

KEY THOUGHT LEADERS INCLUDE:

SPONSOR:

DIRK GILLE, VP, Head of Pharma R&D Quality Assurance, JANSSEN

ELISABETTA DI MARTINO, Clinical Quality Assurance Head,NOVARTIS

JODY SALISBURY, Records Manager Global Records and Information Management, TAKEDA

PRAMOD WABLE, MSC., MRQA, QA Manager, GCP, DAIICHI SANKYO

CLAUDIA KRIEBAUM, Manager, Medical Quality, ELI LILLY

ROGER WARDE, Associate Director - Global GMP Compliance Leader, BIOMARIN

RAKESH GOSWAMI, Manager R&D, BRISTOL LABORATORIES LIMITED

SUSANNE MATHIAS, Senior GCP Advisor, Global Clinical Compliance, NOVO NORDISK A/S

PERNILLE GAD, Senior GCP Advisor, Specialist, Global Clinical Compliance, NOVO NORDISK A/S

NANCY MEYERSON-HESS, B.A., MPHIL, Head, Quality Management, GRÜNENTHAL

CELIA GIBSON, Senior GCP Auditor, NORGINE

ROBERT C. EDWARDS, Senior Clinical Operations Manager, Site Management & Monitoring, UK, ABBVIE

COMMUNICATION TRAINING OVERSIGHT METRICS GCPINSPECTIONREADINESS

FOR MORE INFORMATION VISIT WWW.EXLEVENTS.COM/EUROINSPECTIONS

Brendan Weiss

Conference Producer

European Clinical Trials Inspection

Readiness Summit

[email protected]

ExL Events

Eric Morrin

Business Development Manager

European Clinical Trials Inspection

Readiness Summit

[email protected]

ExL Events

WHO SHOULD ATTEND:This conference is designed for professionals from pharmaceutical, biotech, medical device and clinical research organizations with responsibilities in the following areas:

• Quality Assurance/Quality Control/Quality

Compliance/Quality Management

• Clinical Operations

• Records/Data Management

• Clinical Trials Management

• TMF/eTMF

• Clinical Monitoring

• Global Compliance

• Pharmacovigilance

• Clinical Research

• Safety and Risk Management/Operations

• Auditing

• Clinical Development/Project Management

• Document Coordinator

• Site Management

• Global Regulatory Affairs

BY INDUSTRY:

○ Clinical Operations

○ Compliance

○ Quality

○ R&D

○ Other

○ Pharma/Biotech/ Medical Device

○ CRO

○ Technology Vendor

○ Consultant

70%

15%

10%

5%

BY FUNCTION:

50%

15%

15%

13%

7%

VENUE:Hilton London Kensington 179-199 Holland Park Ave, London W11 4UL UK, Phone +44 207-603-3355

Room Reservations: To make reservations please call +44 207-603-3355, option 1, and provide the group

code ‘GEXLA’ to receive the negotiated rate. The group rate is available until April 1, 2015. Please

book your room early as rooms available at this rate are limited.

DEAR COLLEAGUE,

As an industry professional you know how crucial it is to be prepared for regulatory

inspections at your clinical trial sites. Maintaining inspection readiness during a trial

means managing a constantly evolving set of processes that must be in place in order

to ensure an inspector can be given immediate and complete access to clinical trial

records. Sponsor companies need to be at the helm of the effort to remain compliant

— which is a huge burden to bear.

Sponsor companies must evaluate potential clinical trial partners, defi ne clear

responsibilities for each stakeholder and attain top-notch document quality, at

the same time ensuring that all relevant information is accessible to investigators

whenever they may arrive. Sponsors must be conscious that they are ultimately

responsible for the actions of the CRO and site during the clinical trial and must take

ownership of compliance issues. Anything less than complete GCP compliance can

result in heavy fi nes and a loss of reputation in the market.

The European Clinical Trials Inspection Readiness Summit provides attendees with

lessons learned by industry speakers who have fi rsthand experience preparing for an

inspection. Additionally, this conference will allow delegates to leave the event armed

with best practices in partner oversight, metrics, data quality, TMF, legacy system

interoperability and risk assessment tools; a better understanding of what health

authorities command; and the confi dence needed to bring SOPs to the table for

company-wide implementation.

Our expert thought leaders will provide unique perspectives and case studies in

sessions such as:

• Identify What an Inspector is Looking for During an Inspection • Best Practices for Effective Oversight and Management of CROs • Effective CRO Benchmarks and Relevant Metrics• TMF Inspection Preparedness, Remediation and Archiving• Steps to Take After Receiving a Warning Letter to Avoid Future Mistakes• Training Site Staff to Prepare for Clinical Inspections• The Rise of Pharmacovigilance Increased Importance and Regulations Changes

Join clinical operations, quality assurance and records management professionals to

discuss best practices for developing and managing an inspection readiness process

that ensures ongoing compliance and the continued passage of trial inspections.

We look forward to seeing you in London this April!

Sincerely,

AUDIENCE PROFILE


WORKSHOP THURSDAY, 23 APRIL 2015CA

SE S

TUDY

AGENDA DAY 1 THURSDAY, 23 APRIL 2015

PANE

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“This has been the best conference I have ever attended. The speakers have all been great and the use of humor in several presentations is a welcome relief to information that is often tedious.” CCRP, MAYO CLINIC

12:00 Main Conference Registration

13:00 CHAIRPERSON’S OPENING REMARKS

13:15 CASE STUDY: IMPLEMENTING INITIATIVES TO BUILD INSPECTION READINESS INTO CORPORATE CULTURE

� Lead interdepartmental exercises that stress the importance of inspection readiness

� Educate upper management on their role during an inspection

� Build cross-functional teams that will work well together under the pressure that comes with being inspected

Nancy Meyerson-Hess, B.A., MPhil, Head, Quality Management, GRÜNENTHAL

14:00 BEST PRACTICES FOR EFFECTIVE OVERSIGHT AND MANAGEMENT OF CROS

� Develop strategies to ensure that your CRO is GCP compliant

� Provide suf� cient training on new technologies to avoid receiving a warning letter after an inspection

� Employ a system to ensure the reliable correction of any identi� ed problems or issues

Dirk Gille, VP, Head of Pharma R&D Quality Assurance, Janssen

15:00 EFFECTIVE CRO BENCHMARKS AND RELEVANT METRICS � Establish set responsibilities and ownership of duties at the beginning

of the relationship

� Set up timely and responsive communication pathways

� Develop metrics to measure the quality of operations in outsourced trials

� Monitor quality of response to � ndings

Elisabetta Di Martino, Clinical Quality Assurance Head, NOVARTIS

15:45 A� ernoon Networking Break

16:15 TMF INSPECTION PREPAREDNESS, REMEDIATION AND ARCHIVING TO REMAIN GCP COMPLIANT

� Identify different ways you can provide content to an inspector

� Be prepared to reveal your internal inspection process itself as a potential object of an audit

� Put protection in place to keep information secure when sharing information and be prepared to demonstrate this protection to regulators

Jody Salisbury, Records Manager Global Records and Information Management, TAKEDA

17:00 PANEL DISCUSSION: STEPS TO TAKE AFTER RECEIVING A WARNING LETTER TO AVOID FUTURE MISTAKES

� Study an overview of warning letters and lessons learned in the wake of receiving a warning letter

� Learn what steps were taken in regard to vendor management

� Examine how on-site staff were trained to better manage risk going forward

Claudia Kriebaum, Manager, Medical Quality, ELI LILLY

Roger Warde, Associate Director - Global GMP Compliance Leader, BIOMARIN

Rakesh Goswami, Manager R&D, BRISTOL LABORATORIES LIMITED

18:00 Conclusion of Day One

8:15 Workshop Registration Opens and Continental Breakfast

9:00 WORKSHOP: MOCK INSPECTION BEST PRACTICES TO ENSURE YOUR INTERNAL AUDITING PROCESSES WORKThe motivation behind GCP inspection is to ensure the safety of trial subjects and the integrity of the clinical trial. This interactive session, led by a former MHRA inspector, will teach you how to prepare for an inspection by leveraging a mock inspection as an important tool.

� Learn how to conduct a mock sponsor inspection to determine how prepared the organization is

� Discuss how to create a mobilization plan for when noti� cation of an inspection is received

� Delegate roles and responsibilities to key team members and staff

� Plan how to assess the inspection readiness of your key vendors

� Focus on higher compliance risk areas and activities

Workshop Leader: Ian Oulsnam, Compliance Consultant and Auditor, Optima-QA, Former GCP Expert Inspector, MHRA

This workshop will have a 30-minute break.

12:00 Lunch for Workshop Participants


AGENDA DAY 2 FRIDAY, 24 APRIL 2015

“Very effective, well delineated” VP BD, PHLEXGLOBAL

“Perfect size, good location, good content” Principal, ALPHA PRIME CONSULTING

“A lot of learning based on presenter and peer experience…”Lead Advisor, ASTRAZENECA

“Great — speakers were excellent!” Director Clinops, TARSA

“Information was very well presented and valuable” Senior Training Specialist, JANSSEN

“…presentations were relevant and suffi ciently detail appropriate for an experienced audience” Deputy Director, SANOFI

CASE

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TUDY

CASE

STU

DYPA

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CASE

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8:15 Continental Breakfast

8:45 CHAIRPERSON’S OPENING REMARKS

9:00 TRAIN SITE STAFF TO PREPARE FOR CLINICAL INSPECTIONS � Learn what your training program should look like in order to best

manage risk

� Circumvent inadequate case history, which is one of the most relevant inspection oversights

� Teach your staff good documentation practice and keep up with the latest technologies to assist data management

Workshop Leader: Pramod Wable, MSc., MRQA, QA Manager, GCP, DAIICHI SANKYO

9:30 PREPARING FOR GCP INSPECTIONS GLOBALLY — SUPPORT AND FACILITATION

� Delve into inspection/inspectorate intelligence (knowledge on the various inspectorate approaches and types of inspections)

� Follow standard logistical set-up

� Ensure continuous improvement, including follow-up on “near misses”

� Prepare for the next inspection — the follow-up and tracking of commitments

Susanne Mathias, Senior GCP Advisor, Global Clinical Compliance, NOVO NORDISK A/S

Pernille Gad, Senior GCP Advisor, Specialist, Global Clinical Compliance, NOVO NORDISK A/S

10:30 Networking and Refreshment Break

11:00 CASE STUDY: PREPARE FOR AND SURVIVE AN MHRA INSPECTION

� Develop best practices for pre-inspection preparations

� Review steps to take after receiving the con� rmation email with set inspection dates

� De� ne clear roles for each department to ensure that information is accessible to the inspector in a timely fashion

Celia Gibson, Senior GCP Auditor, NORGINE LTD

12:00 Luncheon

13:15 BEST PRACTICES FOR SITE INSPECTION READINESS � Schedule sponsor-conducted inspection readiness visits

� Explore what these visits consist of

� Differentiate inspections from audits

� Show how to conduct mock interviews with site staff

Mallorie Mitchell-Dellac, Senior Manager, Clinical Quality,

14:00 Networking and Refreshment Break

14:30 PANEL DISCUSSION: EMAIL CORRESPONDENCE COLLECTION AND ARCHIVING

� Explain how to determine which emails are important and worth saving – avoid presenting an inspector with a “data dump” of emails

� Explore ways to � le and label emails being kept for inspection purposes

� Review how to best present emails to an inspector for maximum clarity and accessibility

Robert C. Edwards, Senior Clinical Operations Manager, Site Management & Monitoring, UK, ABBVIE

Susanne Mathias, Senior GCP Advisor, Global Clinical Compliance, NOVO NORDISK A/S

Pernille Gad, Clinical Project Manager, NOVO NORDISK A/S

15:30 INSPECTION READINESS: ALL ONBOARD � Discuss what inspection readiness means for an organization

� Consider how to develop a mindset to encourage various departments to collaborate in implementing activities

� Coordinate activities between support teams to become inspection ready

� Identify gaps and how to proceed once those gaps are identi� ed

� Learn how to best prioritize for optimum performance

Nancy Meyerson-Hess, B.A., MPhil, Grünenthal Innovation-Global Late Clinical Development, Head Quality Management, GRÜNENTHAL GmbH

16:00 CHAIRPERSON’S CLOSING REMARKS

16:15 Conference Conclusion


PRICING INFO:

EARLY BIRD RATE — Register by 13 March 2015

Conference & Workshop £1.395Conference Only £1.295

STANDARD RATE


ONSITE RATE


GROUP DISCOUNT PROGRAMSOffers cannot be combined, early bird rates do not apply. To find out more on

how you can take advantage of these group discounts, call +1 866-207-6528.

Save 25% per person when registering fourFor every three simultaneous registrations from your company, you will receive a

fourth complimentary registration to the program (must register four at one time).

Save 15% per person when registering threeCan only send three? You can still save 15% off of each registration.

PAYMENTMake checks payable to ExL Events, Inc. and write code C625 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the

conference date. Any discount applied cannot be combined with any other offers and must

be paid in full at the time of order. Parties must be employed by the same organization and

register simultaneously to realize group discount pricing options.

**Please note, there will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within � ve business days of any ExL conference.**Cancellation and Refund PolicyIf you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another

ExL event valid for 12 months from the voucher issue date.• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher

issue date.If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less.To receive a refund or voucher, please fax your request to +1 888-221-6750.

Substitution ChargesThere will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within � ve business days of the conference.ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel or any other costs incurred by registrants.

ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speakers or venue.

*The opinions of ExL speakers do not necessarily re� ect those of the companies they represent, nor ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, signi� cant effort to � nd a suitable replacement will be made.

Sponsorship and Exhibition OpportunitiesDo you want to spread the word about your organization’s

solutions and services to potential clients who attend

this event? Take advantage of the opportunity to exhibit,

present an educational session, host a networking event

or distribute promotional items to attendees. ExL works

closely with you to customize a package that suits all of

your needs.

To learn more about these opportunities, contact

Eric Morrin, Business Development Manager,

at +1 212-400-6228 or [email protected].

MEDIA PARTNERS REGISTRATION INFORMATION

Questions? Comments? Do you have a question or comment you would like

to be addressed at this event? Would you like to get

involved as a speaker or discussion leader? Please

email Program Director Brendan Weiss

at [email protected].

WAYS TO REGISTER

ExL Events, Inc.494 8th Ave, Fourth FloorNew York, NY 10001

www.exlevents.com/euroinspections

[email protected]

+1 866-201-6528

+1 888-221-6750

CLINICAL TRIALS INSPECTION READINESS SUMMIT


EUROPEAN

THE ONLY EVENT FOCUSED ON GCP INSPECTION READINESS IN THE EU!


COMMUNICATION TRAINING OVERSIGHT METRICS GCP INSPECTIONREADINESS

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CLINICAL TRIALSINSPECTION READINESS SUMMIT



COMMUNICATION TRAINING OVERSIGHT METRICS GCP INSPECTIONREADINESS

SPONSOR:


ExL Events, Inc.494 8th Ave, Fourth FloorNew York, NY 10001

www.exlevents.com/euroinspections

[email protected]

+1 866-207-6528

+1 888-221-6750

Documents

THE ONLY EVENT FOCUSED ON GCP INSPECTION …info.exlevents.com/rs/exlevents/images/C625_final.pdf• Global Compliance • Pharmacovigilance • Clinical Research • Safety and Risk