Conference Hashtag - #VI_Pharma

6th Pharmacovigilance 2014

04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK
Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance drug safety and risk management

KEY SPEAKERS INCLUDE:Joan Francesc Aregall Picamal, Pharmacovigilance Country Head, Bayer William Gregory, Director, Safety and Risk Management, Pfizer Christina Strom Moller, Vice President - Patient Safety Late Development & Marketed Products, AstraZeneca Arlene Gallagher, Statistician, Epidemiologist Clinical Practice Research Datalink, MHRA Ashish Kohli, Senior Director-Established Products Regulatory Portfolio Lead EU/Aus/NZ, Pfizer Julia Appelskog, EU QPPV, Bluefish Pharmaceuticals Susanne Ramm, Head of Medical Science & Affairs, Dr. Ebeling & Assoc Andrew Cochrane, Deputy EU QPPV, Novartis Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk Phillip Eichorn, Senior Director, Pfizer Sumit Munjal, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Oncology: Millennium Pharmaceuticals Nicolas Limbos, Senior Drug Safety Scientist, Keyrus Biopharma Franziska Albrecht, Senior Pharmacovigilance Advisor, Dr. Ebeling & Assoc

Maarten Van Baelen, Medical Affairs Manager, EGA (European Generic Medicines Association) Vito Strasberger, CEO, Nanokinetik Steinar Madsen, Medical Director, Norweigen Medicines Agency Vid Stanulovic, Medical Safety Officer, Aprova David Jefferys, Sr. VP Regulatory, Eisai Pharmaceuticals Paul Dolin, Senior Director, Takeda Pharmaceuticals Caroline Pastor, Pharmacovigilance Operations Manager, Aprova Pipasha Biswas, Director & QPPV, PV & Pharmacoepidemiology, Symogen John Talbot, Senior Lecturer, Pharmacovigilance, University of Hertfordshire Deborah Layton, Principal Research Fellow, Drug Safety Research Unit (DSRU) Fiona Maini, Sr. Manager, Deloitte Consulting Joanna Hook, Associate, Bristows

6th Pharmacovigilance 2014 04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK

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6th Pharmacovigilance 2014 04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK
CONFERENCE INTRODUCTION:New European Union (EU) pharmacovigilance legislation was adopted by the European Parliament and Council of Ministers in December 2010. Many of the new provisions contained in the legislation have been effective since July 2012. It is estimated that the average spend on pharmacovigilance is 6% to 13% of a companies total R&D. From product development in clinical trials to post marketing surveillance, adverse drug reactions are monitored and safety signals investigated. The new legislation includes sweeping changes that leave industry with a lot of questions. If you want to file your product in Europe (MAA), what new PV regulatory processes do you need to put in place? Will the Pharmacovigilance System Master File be useful? And what is really meant by a Quality Management System? The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. 6th Pharmacovigilance 2014 is the latest in Virtue Insights series of successful pharmacovigilance events. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development It gives me great pleasure in welcoming all of you to the Virtue Insights 6th Pharmacovigilance 2014. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.

KEY THEMES DISCUSSED AT THIS CONFERENCE: Fiercest technologies, methodologies and introducing pharmacy automations on work practices of Pharmacovigilance in EU & US PRAC & European Pharmacovigilance legislation - Implementation and Beyond Updating yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV How will PV activities change with Clinical trial transformation initiative? Pharmacovigilance system master file Audit and Inspection: Realistic steps for a fruitful consequence Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models Exploiting the pharmacy automations and technologies for enhancement of medication safety Impact of technology learn and explore Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions Determining the steps and strategies for enhancing quality in healthcare Signals: From detection to validation Review the use of Periodic Safety Update Reports (PSURs) post-authorisation for safety signals Legislative framework, including GVP modules Dwell ahead of regulatory developments & improving your risk management strategies in a cost effective way in EU, US Accelerating new medicine introduction in developing world & overcoming challenges Explaining how to use the data sources and observational research for effective safety analysis Be part of a major networking opportunity

WHO SHOULD ATTEND? VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of: Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacology, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance, Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing

WHY SHOULD YOU ATTEND? 6th Pharmacovigilance 2014 Uniting Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

6th Pharmacovigilance 2014 04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK
DAY ONE - 04TH MARCH 2014
08:30 Coffee and registration An opportunity to meet and to network with your conference colleagues. 09:30 Chairperson opening remarks Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk
(http://www.linkedin.com/pub/merete-schmiegelow/6/874/127)

Sumit Munjal, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Oncology: Millennium Pharmaceuticals
(http://www.linkedin.com/pub/sumit-munjal/17/400/410)

Joan Francesc Aregall Picamal, Pharmacovigilance Country Head, Bayer (http://www.linkedin.com/pub/joan-francesc-aregallpicamal/26/582/298)

Pipasha Biswas, Director & QPPV, PV & Pharmacoepidemiology, Symogen

(http://www.linkedin.com/pub/pipasha-biswas/0/b93/859)

MARKET OVERVIEW & ANALYSIS

09:40 Morning Keynote Address 1 Company webpages and social media presence. PV implications Legal requirements Guidelines Presence of PV on the Internet

12:00 Signal Management and Continuous Benefit-Risk Assessment (CoBRA) including synergies with PSURCompilation Legislative and regulatory guidance (GVP) Strategical and systematical approach for screening of sources Linking signal detection, continuous benefit-risk assessment and Emerging Safety Issues Evaluation and validation of potential signals in practice Considerations for and consequences of potential & identified risks CoBRA reports for use with respect to PSUR compilation Quality assurance and traceability of Signal Management and CoBRA

Joan Francesc Aregall Picamal, Pharmacovigilance Country Head, Bayer (http://www.linkedin.com/pub/joan-francesc-aregallpicamal/26/582/298)

10:20 Morning Keynote Address 2 Lessons learned from management of safety data from patient support and market research programs Overview of legal requirements Perspectives in handling of safety information Collaborations with service provider

Susanne Ramm, Head of Medical Science & Affairs, Dr. Ebeling & Assoc 12:40 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting...

Julia Appelskog, EU QPPV, Bluefish Pharmaceuticals

(http://www.linkedin.com/pub/julia-appelskog/1b/559/a68)

11:00 Morning Coffee/Tea & Discussion

BUSINESS MODELS CHALLENGES & OPPORTUNITIES

14:00 Afternoon Keynote Panel Discussion: Why does pharmacovigilance fail and where could fault lie? 11:20 Keynote Panel Discussion: Challenges and Opportunities in PV lifecycle management Staying ahead in the race - Update on PV in EU, USA & RoW Current trends for PV, and new and future guidelines Operational implications for integration of the new European pharmacovigilance legislation for pharma Litigation, risk and latest developments and trends within PV technology Guideline on GVP in EU Overview of the key elements for Post-authorisation Safety Studies (PASS) and Post-authorisation Efficacy Studies (PAES) Adequate sharing of information between stake holders No rapport with practising physicians & peripheral centres Increasing availability of drugs, due to which too many drugs and irrational combinations and aggressive marketing Irrational practice of treatment without provisional diagnosis, Wrong choice & incorrect dose, lack of documentation, resultant medical errors leading to ADEs and not necessarily ADRs Pharmacovigilance Audits from a Sponsors Perspective: Risk Management Plans (RMPS) & Risk Evaluation Mitigation Strategy (REMS)

Moderator: Moderator: Fiona Maini, Sr. Manager, Deloitte Consulting

(http://www.linkedin.com/pub/fiona-maini-pmp/1/1b8/b81)

Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk
(http://www.linkedin.com/pub/merete-schmiegelow/6/874/127)

Panellists: William Gregory, Director, Safety and Risk Management, Pfizer

Panellists: Christina Strom Moller, Vice President - Patient Safety Late Development & Marketed Products, AstraZeneca
(http://www.linkedin.com/pub/christina-strom-moller/7/954/81a)

Steinar Madsen, Medical Director, Norweigen Medicines Agency John Talbot, Senior Lecturer, Pharmacovigilance, University of Hertfordshire (http://www.linkedin.com/pub/john-talbot/31/500/b14)

6th Pharmacovigilance 2014 04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK
14:40 Pharmacovigilance Systems Crisis Crises in pharmacovigilance system occur for several reasons: Audit/inspection findings probably top the list. A newly discovered safety concern for a drug frequently reveals deficiencies in the system. Or it may be just a risk identified by regulatory authorities which requires action. Whatever the cause for the crisis, the PV systems may suddenly become a hot topic and endanger a companys very existence. The question is: where to start fixing it? Shall it be new procedures? Database? Qualified personnel? Training? Regulatory consultation? Outsource or hire? Vid Stanulovic, Medical Safety Officer, Aprova
(http://www.linkedin.com/pub/vid-stanulovic/4/237/3b6)

DAY TWO - 05TH MARCH 2014

08:30 Coffee and registration An opportunity to meet and to network with your conference colleagues. 09:30 Chairperson opening remarks Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk
(http://www.linkedin.com/pub/merete-schmiegelow/6/874/127)

RISK MANAGEMENT & PLANNING

09:40 Morning Keynote Address 1 Risk Management Plans up-to-date New guidance on the definition of important risks What are the key challenges that we now face with RMPs Risk minimization strategies Cutting-edge risk management, how to prepare for the worst What are the key challenges that we now face with global and local RMPs Measuring the effectiveness of risk management measures and ensure compliance with the regulatory requirements Risk Management: FDA vs. EMA

Caroline Pastor, Pharmacovigilance Operations Manager, Aprova (http://www.linkedin.com/pub/caroline-pastor/42/89a/a0b) 15:10 Afternoon Tea/Coffee

TECHNOLOGY IMPACT
15:30 - IT solutions for Pharmacovigilance

Vito Strasberger, CEO, Nanokinetik

(http://www.linkedin.com/pub/vito-strasberger/18/214/211)

SAFETY SIGNAL DETECTION

16:00 Signals: From detection to validation What are the challenges in signal validation? Role and differences of classical and statistical signal detection in the ongoing safety surveillance of medicinal products Outline how to apply signal detection within their function based on the possibilities and limitations of methodology and data Utilizing information gained through improved collaboration to better investigate signals and find potential issues with your drug Rising internal communication to guarantee that signals are discovered as quickly as possible and investigated to the best of the companies ability Calculating differences between signal detection in clinical trials & post-authorization to develop appropriate action plans for both

Franziska Albrecht, Senior Pharmacovigilance Advisor, Dr. Ebeling & Assoc 10:20 Morning Keynote Address 2 The transition to the new EU RMPan industry perspective Challenges in converting existing RMPs to the new structurelessons learned Benefits and pitfalls of the new RMP structure Approaches to the new templatepain points and future directions Modularity and synergy with the PSUR/PBRER and DSUR Managing resource under the new requirementsmore RMPs, fewer updates?

Phillip Eichorn, Senior Director, Pfizer

(http://www.linkedin.com/pub/phillip-eichorn/27/b15/a2b)

11:00 Morning Coffee/Tea & Discussion

Pipasha Biswas, Director & QPPV, PV & Pharmacoepidemiology, Symogen

(http://www.linkedin.com/pub/pipasha-biswas/0/b93/859)

SPONSOR SITE - CRO

11:20 - Outsourcing Pharmacovigilance: Use a secure web-base interface to develop a collaborative partnership between Sponsor and CRO supported by Integrated, standardized global IT data sharing and communication Nicolas Limbos, Senior Drug Safety Scientist, Keyrus Biopharma

16:30 - Experience with EU Risk Management Plans and how to assess their effectiveness Background to RMPs, legislation and guidance Experience with EU RMPs to date The new EU RMP Structure (GVP Module V) Risk minimisation measures and assessing their effectiveness (GVP Module XVI) Examples of measurement of effectiveness

John Talbot, Senior Lecturer, Pharmacovigilance, University of Hertfordshire (http://www.linkedin.com/pub/john-talbot/31/500/b14) 17:00 - Chairpersons closing remarks and end of conference Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk
(http://www.linkedin.com/pub/merete-schmiegelow/6/874/127)

17:10 - 18:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting.

6th Pharmacovigilance 2014 04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK
12:00 A Researchers perspective of Risk Management Planning Fulfilling the need for innovation Understanding the local health services in practice Study design considerations Real-life case examples

REGULATION OVERVIEW & UPDATE

16:20 Panel Discussion: The developing regulatory framework in advanced and developing markets for Today & Tomorrow A brief recap of recent regulatory developments. Ensuring you comply with market requirements Issues with implementation of new regulations for the master file Regulatory updates and GVP modules overview Current PV practices in the EU PRAC: Initial Assessment regulatory & industry perspective

Deborah Layton, Principal Research Fellow, Drug Safety Research Unit (DSRU)
12:40 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting...

Moderator:

DATA COLLECTION & MANAGEMENT

14:00 Using Real World Evidence in Pharmacovigilance and Drug Safety The Clinical Practice Research Datalink Primary care data on 5million+ active patients with external record linkage to other NHS data sets Up-to-date estimates of exposure Drug use in real clinical practice Background rates of adverse events Post-authorisation safety studies (PASS) Novel use: pragmatic trials

Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk
(http://www.linkedin.com/pub/merete-schmiegelow/6/874/127)

Panellists: Ashish Kohli, Senior Director-Established Products Regulatory Portfolio Lead EU/Aus/NZ, Pfizer
(http://www.linkedin.com/pub/ashish-kohli/4/a3a/11a)

Maarten Van Baelen, Medical Affairs Manager, EGA (European Generic Medicines Association)
(http://www.linkedin.com/pub/maarten-van-baelen/4/200/544)

David Jefferys, Sr. VP Regulatory, Eisai Pharmaceuticals

Arlene Gallagher, Statistician, Epidemiologist Clinical Practice Research Datalink, MHRA (http://www.linkedin.com/pub/arlenegallagher/5b/371/b82)

(http://www.linkedin.com/pub/david-jefferys/10/172/10)

Joanna Hook, Associate, Bristows

(http://www.linkedin.com/pub/joanna-hook/1a/a9b/57)

14:40 - Standards for PSPs and marketing programs after an MHRA inspection History of PSPs and inspection findings Defining quality standards for marketing programs Remediation of ongoing programs Conclusions
17:00 - 17:10 Chairpersons closing remarks and end of conference & End of the 6th Pharmacovigilance 2014 Merete Schmiegelow, Sr Director - EU Regulatory Advocacy Regulatory Policies & Intelligence, Novo Nordisk
(http://www.linkedin.com/pub/merete-schmiegelow/6/874/127)

Andrew Cochrane, Deputy EU QPPV, Novartis

(http://www.linkedin.com/pub/andrew-cochrane/57/b26/394)

15:20 Afternoon Tea/Coffee 15:40 Practical aspects of a drug utilization PASS study Paul Dolin, Senior Director, Takeda Pharmaceuticals
(http://www.linkedin.com/pub/paul-dolin/4/439/22b)

6th Pharmacovigilance 2014

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6th Pharmacovigilance 2014 04th & 05th March 2014, Thistle Marble Arch Hotel, London, UK

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