PLUS AN INTERACTIVE POST-CONFERENCE WORKSHOPWednesday 16th March 2011, Copthorne Tara Hotel, London, UK

Optimizing Pharmacovigilance in AffiliatesHosted by Katja Kusche, Global Head of Safety Science for Mature Products, Hoffmann-La Roche

8.30am – 1.00pm

SMi present their 2nd annual conference on...

PharmacovigilanceMonday 14th & Tuesday 15th March 2011Copthorne Tara Hotel, Central London, UK

REGISTER BY 17TH DECEMBER AND RECEIVE A £200 DISCOUNT

www.smi-online.co.uk/2011pharmacovigilance.aspRegister online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Pharmacovigilance is now morenecessary than ever. With the sharpincrease in product recalls andlitigation cases in recent years, theneed to scrutinise a drugs activity and effect from pre- to post-development has become ofparamount importance.

Peter SchiemannGlobal Head of Quality Risk Management,Hoffmann-La Roche

Stewart GearyVice President, Deputy Director, Corporate Regulatory Compliance andQuality Assurance Headquarters,Eisai

Mariska Kooijmans-Coutinho, Vice President Drug Safety and Risk Management, and QPPV, Biogen Idec

George McCormick, Vice President, Drug Safety & Disposition, Cephalon

Shelley GandhiUnit Manager-Signal Management GroupVigilance & Risk Managementof Medicines, MHRA

Karen PattendenSenior Director Drug Safety & Public Health/EEA QPPV,Gilead Sciences International

Michèle SangeleerMedical Information & Pharmacovigilance Manager, Eli Lilly

KEY SPEAKERS

CONFERENCE HIGHLIGHTS• Preparing for and surviving PhV inspections• Risk management and internal auditing strategies• Periodic safety reporting and the Development Safety

Update Report (DSUR)• Post-marketing surveillance activities and EudraVigilance

PharmacovigilanceDay One | Monday 14th March 2011

Register online at www.smi-online.co.uk/2011pharmacovigilance.asp • Alte

www.smi-online.co.uk/20

8.30 Registration and coffee

9.00 Chairman's opening remarksPeter Schiemann, Global Head of Quality Risk Management,Hoffmann-La Roche

INSPECTIONS AND AUDITING

9.10 Practical issues in Pharmacovigilance inspections• Case study: A 2010 MHRA PhV inspection in Stirling, Scotland • Internal and external communication• Obstacles, surprises, practical recommendations• Expenditure of time and costs• The importance of team work• Be calm and keep your sense of humour!Mechthild Waldeyer, Head Pharmacovigilance Department, medacGmbH

9.50 Quality risk management as the quality management principle• What are regulators expecting from a Quality Management System?• Quality Management in Pharmacovigilance - How is it done?• Preparing for the challenge of risk based inspectionsPeter Schiemann, Global Head of Quality Risk Management,Hoffmann-La Roche

10.30 Morning coffee

11.00 Managing clinical safety when manufacturing experiencessignificant glitches • Safety monitoring of medicines• Implementing an effective response action plan• Case studiesMariska Kooijmans-Coutinho, Vice President Drug Safety and RiskManagement, and QPPV, Biogen Idec

11.40 Inspections... Are you ready?• Background to inspections • Pharmacovigilance inspections scope • Common inspection findings• Inspection preparation so you are inspection ready • Personal inspection experience• Survival tips from experience Karen Pattenden, Senior Director Drug Safety & Public Health/EEAQPPV, Gilead Sciences International

12.20 Preparing for and surviving PV inspections• The legal obligations of a QPPV• Safety audits• Supporting Pharmacovigilance Qualified Persons and Responsible

Person• Clarifying the level of appropriate training for qualified and

responsible personsMary O'Hare, Compliance Area Lead, Pharmacovigilance,Astrazeneca

1.00 Networking lunch

RULES AND REGULATIONS

2.00 Periodic safety reporting during clinical development and the DSUR• Purpose and rationale for periodic reporting during clinical

development• Current regulations for periodic reporting during clinical

development• The US IND Annual Report, European Annual Safety Report and

Japanese 6-monthly Periodic Report During Development• ICH E2F and the DSUR• The challenges for preparing the DSURStewart Geary, Vice President, Deputy Director, Corporate RegulatoryCompliance and Quality Assurance Headquarters, Eisai

2.40 Pharmacovigilance inspections involving the MHRA and FDA• Keeping up with challenging new regulations to ensure compliance• Effectiveky implementing new legislation• Aspiring towards global harmonisationPatricia Bocciarelli, International Pharmacovigilance Expert ClinicalQuality & Compliance, Sanofi-Aventis

3.20 Afternoon tea

3.50 Panel Discussion‘‘The impact of new legislation on pharmacovigilance activities andthe harmonisation of new regulations – An InternationalPerspective’Stewart Geary, Vice President, Deputy Director, EisaiMariska Kooijmans-Coutinho, Vice President Drug Safety and RiskManagement, and QPPV, Biogen IdecVijay Annapareddy, Senior Pharmacovigilance Specialist,Sanofi- Aventis

4.30 Recent changes to the pharmacovigilance legislation• Impact of new legislation• Development safety update reports (ICH E2F)• New rules on Pharmacovigilance enabling patients and health

professionals to work more effectively together• An increased level of transparency of safety information.Vijay Annapareddy, Senior Pharmacovigilance Specialist, Sanofi- Aventis

5.10 Chairman’s closing remarks and close of day one

Supported by

Delegate BreakdownDelegates at our last year’s Pharmacovigilanceconference came from a wide range of Euro-centriclocations, and represented a diverse range of currentopinions regarding the current drug safety practices.Whilst stimulating debates arose amongst some of thelargest international pharmaceutical organisations.

Who should attend:

8.30 Re-registration and coffee

9.00 Chairman's opening remarksMariska Kooijmans-Coutinho, Vice President Drug Safety and RiskManagement, and QPPV, Biogen Idec

RISK MANAGEMENT AND SAFETY

9.10 Drug safety in early phase oncology trials - Case studies• A non-commercial sponsor’s perspective• Early phase oncology trials in patients• Recurring themes in case studies:

- Underlying illness vs. Disease progression vs. Safety signals- Dealing with independent expert reviews (IMP quality issue with an

impact on safety)• Internal decision making processes and communicationCatarina Macedo, Pharmacovigilance Manager, Cancer Research UK

9.50 Optimizing the clinical safety contribution to the management ofmanufacturing quality issues• Approach for medical assessments for product complaints possibly

impacting patient’s safety• Challenges for clinical safety• Organizational structure to allow high quality medical assessments• Monitoring the safety database for events which may result from

product defectsBarbara Donner, Global Head of Safety Science Business Support,Hoffmann-La Roche

10.30 Morning coffee

11.00 Risk management – What are we learning?• Relationship between safety specification and risk management• Developing strategies to answer relevant questions• Managing the stakeholdersSaad Shakir, Director, Drug Safety Research Unit (DSRU)

11.40 Managing benefit/risk for mature medicines: A case study• Mature products' BR can be challenged after decades on the market• External researches generating new data and hypotheses• Poor quality data in house: Case data from spontaneous reporting

and 'historic' dossiers• Lack of expertise - Need to reach out to experts in the disease area • Limited awareness of the needs for continued support of these

products in a development organisation• Resource constraints while health authority expectations and

demands are growingKatja Kusche, Global Head of Safety Science for Mature Product,Hoffmann-La Roche

12.20 Adverse event(s) reporting from a non-clinical safety perspective• Relationship between safety specification and risk management• What constitutes the necessity to report Adverse Events / Serious

Adverse Events (SAE) / Adverse Drug Reactions (ADR) clinically• Non-clinical safety assessment in support of clinical safety• Traditional endpoints in non-clinical safety testing

• Predictability of non-clinical safety (animal safety testing) results todrug/chemical-induced safety in humans

• Classification of toxicities that may be expected during the course oftoxicology testing

• Non-clinical adverse events reporting to domestic and internationalregulatory agencies

George McCormick, Vice President, Drug Safety & Disposition,Cephalon

1.00 Networking lunch

POST-MARKETING ACTIVITIES

2.00 Pharmacovigilance in promotion: Necessity or argument?• The legal and deontological requirements for fair safety info in

informational/promotional materials for HCPs (including timelines) • The challenges of wording and presentation • The role of the QPPV and the legal responsible for material review:

How far do they have to go? • The DDLs and risk management activities integrated in promotion • The reaction of European customers (HCP, patients, etc) to safety

informationMichèle Sangeleer, Medical Information & PharmacovigilanceManager, Eli Lilly

2.40 Signal detection in the UK• Challenges faced by Signal Management systems• The tools used for Signal data management at MHRA?• Signal Evaluation and Prioritisation • Is data quality important for signal generation?• What are the future challenges in this area?Shelley Gandhi, Unit Manager-Signal Management GroupVigilance &Risk Management of Medicines, MHRA

3.20 Afternoon tea

3.50 Management of safety data from related research activities• Registration of clinical activities in a company tracking database• Minimum requirements for safety data collection• Vendor contract and the program protocol/description (if applicable)

will contain the applicable safety language• Vendor safety trainingHeide Cunning, Director, Safety Operations, Ortho-Mcneil Janssen (A Johnson and Johnson Company)

4.30 Improved pharmacovigilance reporting system for effective drugsafety management• The benefits of an adequate IT solution to drug safety management• The importance of implementing a standardised data management

system • Regulatory requirementsRonald Meyboom, Medical Adviser, World Health Organisation (WHO)

5.10 Chairman’s closing remarks and close of conference

rnatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

PharmacovigilanceDay Two | Tuesday 15th March 2011011pharmacovigilance.asp

Want to know how you can get involved? Interested in promoting your pharmaceutical services

to this market?Contact Margaret Mugema,

SMi Marketing on +44 (0)20 7827 6072, oremail: mmugema@smi-online.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tailored to complement your company’smarketing strategy. Prime networking opportunities exist toentertain, enhance and expand your client base within the contextof an independent discussion specific to your industry. Should youwish to join the increasing number of companies benefiting fromsponsoring our conferences please call: Alia Malick on +44 (0) 207827 6168 or email: almalick@smi-online.co.uk

Executive Directors, Vice Presidents, Directors,Heads, Managers, Team Leaders of:

Who should attend:

• Patient Recruitment• Pharmacovigilance• Pharmacoepidemiology• Pharmacogenomics• Drug/Product Safety• Drug Development• Clinical Pharmacology

• Information and Clinical Data Management

• Clinical Safety• PSUR• Risk Management• Research & Development• Quality Assurance

HALF DAY POST-CONFERENCE WORKSHOPWednesday 16th March 2011

8.30am – 1.00pmCopthorne Tara Hotel, London, UK

Optimizing Pharmacovigilance in Affiliates

Overview of WorkshopDeveloping and maintaining an effective system for themonitoring of clinical trial status and activities in affiliateand outsourced organisations is essential. This runsespecially true when the number of affiliates and theirexternal partners can number in the hundreds. The aim ofthis briefing is to address the importance of working withyour affiliates in order to ensure optimalpharmacovigilance, and to ensure that processes are inplace to enable an oversight by central functions and theEUQPPV. The format of the workshop will be presented asan interactive experience with ideas exchanged, andopportunities will be presented and strategies outlined forovercoming challenges faced when developingPharmacovigilance activities.

Programme will include:• Facts and case studies of key Roche affiliates• Why not knowing what is going on with global affiliates

is a vulnerability to the company• Effective risk management and mitigation

Agenda

8.30 Registration and coffee

8.50 Welcome and introductions

9.00 Introduction into the topic

9.30 Presentation of the Roche initiative tooptimise PV in affiliates

10.00 Discussion: The interaction between globalsafety departments and safety affiliateorganisations

10.30 Morning coffee

11.00 Role and responsibility of Local SafetyResponsible (LSR)

11.30 Exercise/brain storming session• Local study activities - Ways to maintain

central oversight• Cross functional collaboration at the affiliate

- How to link to global drug safety• Local risk management activities and related

assessments

12.30 Wrap up with summary and questions

13.00 Close of workshop

For more information and updates visit the conference websiteat www.smi-online.co.uk/2011pharmacovigilance.asp

About the Workshop Leader:Katja Kusche, MD PhD is an Anaesthesiologist by trainingwith 7 years hospital experience and 13 years in thePharma Industry working on Drug safety. She spent herfirst 3 years on the affiliate level (HMR Germany), and since2000 has worked at the Roche Global Safety RiskManagement division. Katja is currently the Global HeadMature of Products in Safety Science at Hoffmann-LaRoche.

Hosted by Katja Kusche, Global Head of Safety Science forMature Products at Hoffmann-La Roche

ABOUT THE SMi PHARMACEUTICAL TEAMSMi have been involved in the pharmaceutical industrysince 1993 and have developed a series of informativeand niche events, covering the latest issues anddevelopments surrounding the industry. Events bringtogether senior industry professionals and servingcompanies who have a focus on being at the forefrontof developments in this area. SMi aim to generateinformed and topical discussion through the mediumof both conferences and executive briefings. Ourpharmaceutical events are research-based andcontent driven with regular contact with majorindustry personnel and cover a wide range of industrysectors. For more information, please visit www.smi-online.co.uk/pharma.asp

December 201001/02 Cold Chain Distribution

January 201117/18 Pharmaceutical Microbiology19/20 Pre-Filled Syringes24/25 Paediatric Clinical Trials26/27 Social Media for Pharmaceuticals31/01 Biomarkers Summit

February 201102/03 Adaptive Designs in Clinical Drug Development07/08 Pharmaceutical Parallel Trade21/22 Advances and Progress in Drug Design23/24 Stem Cells

March 201107/08 Imaging in Cancer Drug Development14/15 Pharmacovigilance16/17 Superbugs & Superdrugs23/24 Accelerating patient recruitment & Retention in

Clinical Trials 30/31 Controlled Release

April 2011 13/14 Asthma & COPD

May2011 11/12 Generics, Supergenerics and Patent Strategies 16/17 Clinical Trial Logistics

June 201101/02 Pain Therapeutics 27/28 Nanotechnology 27/28 RNAi 29/30 Pharmaceutical Portfolio & Product Lifecycle

Management 29/30 KOL Europe (Munich, Germany)

July 201106/07 BioBanking 06/07 ADMET11/12 Freeze Drying 18/19 Clinical Trial Logistics Asia (Singapore)20/21 Pre-Filled Syringes Asia (Singapore)

All conferences take place in central London, UK – unless indicated otherwise in brackets

PHARMACEUTICALFORWARD PLANNER

PHARMACOVIGILANCEConference: Monday 14th & Tuesday 15th March 2011, Copthorne Tara Hotel, London, UK Workshop: Wednesday 16th March 2011, London

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