This document provides information about the 4th Annual Corporate Compliance & Transparency in the Pharmaceutical Industry conference taking place on February 24-25, 2016 in Zurich. The conference will focus on key issues relating to compliance, disclosure, and transparency in the pharmaceutical industry. It will include an on-stage interview with EFPIA, presentations on implementing disclosure codes and lessons learned, and panels on defining fair market value and optimizing HCP interactions transparently. The event aims to help participants learn how to address compliance challenges, develop consistent transparency strategies, and establish effective investigation procedures.
Ζητήματα εταιρικής συμμόρφωσης, νέα και ισχύουσα νομοθεσία κατά της διαφθοράς, δικαιώματα ασθενή, ασφάλεια και προστασία προσωπικών δεδομένων - σημαντικά ζητήματα που απασχολούν τις εταιρείες που δρουν στον χώρο της υγείας στην Ελλάδα και αλλού.
Regulatory Compliance in the Pharmaceutical Supply ChainAudioEducator
The document summarizes key points about regulatory compliance in the pharmaceutical supply chain. It discusses how the FDA launched initiatives in 2002 to modernize drug manufacturing regulations using modern risk management and quality techniques. This was driven by an increase in adverse drug events and recalls. The FDA introduced new GMP regulations for the 21st century requiring comprehensive patient risk management and manufacturing approaches based on scientific principles. The new regulations can consider all products at a facility "adulterated" if any GMP system fails inspection, potentially wiping out revenue from a single high-risk product. The presentation provides background on these changes to FDA regulation and their impact on the pharmaceutical industry.
This document summarizes a presentation on healthcare compliance. It discusses how mandatory compliance requirements have increased in recent years through various laws and regulations. Specifically, the Affordable Care Act requires companies to have compliance programs with core elements in place by March 2013 or risk exclusion from federal healthcare programs. The presentation recommends that organizations conduct background checks on all employees, licensed and unlicensed, to various degrees to avoid noncompliance penalties that can include fines, damages, and exclusion from Medicare/Medicaid billing. It provides examples where lack of compliance oversight resulted in millions paid in penalties and kickbacks.
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
PharmaSuite manufacturing execution system (MES) software, the new EBR solutionXavier Solà
The document discusses the benefits of implementing an advanced electronic batch recording (EBR) system integrated with a manufacturing execution system (MES) for pharmaceutical manufacturers. It summarizes that such a system can help optimize production processes, speed up time-to-market, reduce costs through greater efficiencies and reduced waste and errors, ease regulatory compliance demands, and enable serialization capabilities to combat counterfeiting as required by emerging regulations. Implementing an EBR/MES system provides opportunities to cut batch review times, lower operating costs, improve inventory management, and support global compliance requirements in a cost-effective manner.
The document discusses the global and Korean pharmaceutical industries and regulations. It provides an overview of SAP Best Practices solutions and Pharmavision add-ons for compliance with FDA 21 CFR Part 11 regulations. Case studies are presented of pharmaceutical companies that successfully implemented SAP Best Practices and Pharmavision.
Ζητήματα εταιρικής συμμόρφωσης, νέα και ισχύουσα νομοθεσία κατά της διαφθοράς, δικαιώματα ασθενή, ασφάλεια και προστασία προσωπικών δεδομένων - σημαντικά ζητήματα που απασχολούν τις εταιρείες που δρουν στον χώρο της υγείας στην Ελλάδα και αλλού.
Regulatory Compliance in the Pharmaceutical Supply ChainAudioEducator
The document summarizes key points about regulatory compliance in the pharmaceutical supply chain. It discusses how the FDA launched initiatives in 2002 to modernize drug manufacturing regulations using modern risk management and quality techniques. This was driven by an increase in adverse drug events and recalls. The FDA introduced new GMP regulations for the 21st century requiring comprehensive patient risk management and manufacturing approaches based on scientific principles. The new regulations can consider all products at a facility "adulterated" if any GMP system fails inspection, potentially wiping out revenue from a single high-risk product. The presentation provides background on these changes to FDA regulation and their impact on the pharmaceutical industry.
This document summarizes a presentation on healthcare compliance. It discusses how mandatory compliance requirements have increased in recent years through various laws and regulations. Specifically, the Affordable Care Act requires companies to have compliance programs with core elements in place by March 2013 or risk exclusion from federal healthcare programs. The presentation recommends that organizations conduct background checks on all employees, licensed and unlicensed, to various degrees to avoid noncompliance penalties that can include fines, damages, and exclusion from Medicare/Medicaid billing. It provides examples where lack of compliance oversight resulted in millions paid in penalties and kickbacks.
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
PharmaSuite manufacturing execution system (MES) software, the new EBR solutionXavier Solà
The document discusses the benefits of implementing an advanced electronic batch recording (EBR) system integrated with a manufacturing execution system (MES) for pharmaceutical manufacturers. It summarizes that such a system can help optimize production processes, speed up time-to-market, reduce costs through greater efficiencies and reduced waste and errors, ease regulatory compliance demands, and enable serialization capabilities to combat counterfeiting as required by emerging regulations. Implementing an EBR/MES system provides opportunities to cut batch review times, lower operating costs, improve inventory management, and support global compliance requirements in a cost-effective manner.
The document discusses the global and Korean pharmaceutical industries and regulations. It provides an overview of SAP Best Practices solutions and Pharmavision add-ons for compliance with FDA 21 CFR Part 11 regulations. Case studies are presented of pharmaceutical companies that successfully implemented SAP Best Practices and Pharmavision.
3rd corporate compliance & transparency in pharmaMarket iT
This document summarizes a conference on corporate compliance and transparency in the pharmaceutical industry to be held in Zurich, Switzerland on February 25-26, 2015. The conference will address topics such as EFPIA disclosure requirements, defining transparency frameworks, preventing corruption, and challenges in emerging markets. It will feature speakers from pharmaceutical companies and industry groups. Attendees will include compliance officers, lawyers, and those involved in corporate responsibility, contracts, auditing, and business conduct.
This document provides information about the "Pharma Compliance Europe" conference taking place on October 7-8, 2015 in London. The conference will bring together senior compliance executives from pharmaceutical companies to discuss challenges in compliance, transparency, and managing relationships with healthcare professionals. It will include keynote speeches, panels, roundtable discussions, and an exhibition on topics such as developing global compliance programs, data privacy laws, monitoring practices, and culture of integrity. The event aims to help compliance professionals benchmark their strategies and programs against industry best practices.
London global transparency pc15105 brochureMarket iT
This document provides information about the "5th Annual Global Transparency Reporting Congress" conference that will take place on April 15-16, 2015 in London. The conference will focus on evolving guidelines for disclosing healthcare professional spending across the globe. It will include sessions on best practices for implementing transparency codes and managing relationships with healthcare professionals. Representatives from EFPIA, ABPI, various pharmaceutical companies, and medical organizations are scheduled to present.
This document announces a conference on evolving guidelines for disclosing healthcare professional spending across Europe. The 6th Annual Global Transparency Reporting Congress will be held on April 7-8, 2016 in Frankfurt, Germany and will feature presentations from transparency reporting professionals from various pharmaceutical companies and industry associations. The conference will provide insights on implementing disclosure guidelines and managing compliance risks related to healthcare professional payments.
This document provides information on the "Discovering the Route to Regulatory Compliance" conference taking place on September 23-24, 2015 in Barcelona, Spain. The conference will address topics related to regulatory compliance with REACH, including preparing for the 2018 registration deadline, managing substances of very high concern (SVHCs) and applications for authorization, substance and dossier evaluation, safety data sheets, and more. It lists keynote speakers from the European Chemicals Agency and industry organizations discussing these topics.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
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2014 Conference- Agenda & Speaker Bios
marcus evans is one of the world's leading providers and promoters of global summits strategic conferences, professional training, in-Company training, business-to-business congresses, sports hospitality and on-line information. The company also owns a leading football club, represents Hollywood stars and produces films and entertainment. To find out more about how you and your organisation can access the very best in business information, please visit us at: www.marcusevans.com
This document provides an agenda and details for the "Anti-Counterfeiting Pharma 2015" conference taking place on March 11-12, 2015 in London. The conference will feature presentations and panel discussions on topics related to anti-counterfeiting strategies in the pharmaceutical industry, including serialisation, supply chain security, legislation, mobile technologies, and tackling online pharmaceutical crime. Prominent speakers will represent organizations such as Sanofi, Shire Pharmaceuticals, MHRA, GS1, and Arnold & Porter LLP. Attendees will include professionals from R&D, supply chain, packaging, and other relevant roles within the pharmaceutical industry.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
This document is a program for the CBI Global Compliance Congress taking place November 18-19, 2015 in Munich, Germany. The program features panels and presentations on various topics related to compliance best practices from industry and government perspectives. Speakers include representatives from EFPIA, IFPMA, Transparency International, various pharmaceutical companies, and regulatory bodies such as the Serious Fraud Office. Breakout sessions will address issues like HCP relationships, third party oversight, transparency reporting, and challenges for small/mid-size compliance programs. An invitation-only CCO Summit is also included on both days.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
This document advertises an international conference on implementing the IDMP standards for pharmaceutical data. The conference will be held in Berlin in June 2015 and will provide opportunities to:
1) Learn how to assess data requirements and analyze interpretations of the IDMP standards from experts;
2) Benchmark your organization's IDMP implementation process with peers from large and mid-size pharmaceutical companies; and
3) Share insights on how the IDMP standards are changing interactions between IT systems, company functions, and regulatory agencies.
Interactive workshops and case studies from major pharmaceutical companies will also be provided. The conference aims to help companies understand, prioritize, and implement strategies to achieve seamless and fully compliant regulatory information management under the new ID
Meet GE Healthcare, Pfizer, Novartis Pharma, Boehringer-Ingelheim Pharma and ...Torben Haagh
The leading European conference on the topic of IDMP Implementation - Impact on Data, Systems and Processes is due to take place in Berlin from 24 – 25 June 2015. Don't miss your chance to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
There are now limited places available, so make sure you secure your conference ticket today! Learn more here:
http://bit.ly/_Agenda-
4th annual Pharma Anti-Counterfeiting 2015Dinesh T
4th Annual Pharma Anti-Counterfeiting 2015 taking place on 08th & 09th September 2015, London, UK
Please contact me :-Dinesh:- dinesh@virtueinsight.co.in
Fleming Europe Agenda - 3rd eMarketing PharmaHaider Alleg
The document provides information about the 3rd Annual Pharma eMarketing Congress taking place from September 11-13, 2013 in Barcelona, Spain. The event will focus on exploring new opportunities in digital marketing and how pharmaceutical companies can best leverage various e-marketing channels. It will feature expert speakers, a pre-conference social media training day, workshops, case studies, and panel discussions on topics such as social media guidelines, mobile marketing, and engaging stakeholders online. Attendees will include senior executives from marketing, communications, and digital departments of pharmaceutical companies. The event aims to provide solutions for challenges faced in e-marketing and discuss best practices for connecting with customers through new channels.
617L17_S Int Compliance, Legal Risks and Corp IntegrityHumera Akram
This document advertises the 12th Advanced Conference on International Compliance, Legal Risks and Corporate Integrity taking place January 31-February 1, 2017 in Frankfurt, Germany. The conference will bring together senior legal and compliance professionals from leading companies and enforcement agencies to discuss challenges in compliance, ethics, and risk management. New sessions at the 2017 conference will focus on anti-corruption, compliance culture, third party risks, and compliance in Latin America. Attendees can earn up to 23.25 continuing professional development credits. The conference has historically drawn over 600 attendees from 250 companies and 29 countries.
The document provides information about the 9th Pharmacovigilance Conference to be held on September 2nd, 2015 in Mumbai, India. It discusses key themes that will be covered including legislation, audits, signal detection, patient safety, and the developing regulatory framework. It outlines the agenda with topics such as PV for biologics, challenges in PV lifecycle management, and the necessary shift of sponsors and CROs from adversaries to partners. The conference aims to bring together representatives from the pharmaceutical industry and regulatory bodies to address issues in pharmacovigilance and risk management. It is intended to help attendees expand their knowledge and network with industry leaders.
SMi Group's 7th annual Biosimilars Europe 2016 conferenceDale Butler
This document provides information about two pre-conference workshops for the 7th Annual Biosimilars Europe conference.
The first workshop focuses on maximizing intellectual property and regulatory rights related to biosimilars. It will cover topics like regulatory data protection, orphan drug exclusivity, supplementary protection certificates, and pediatric rewards. The workshop leaders are partners at Bristows LLP.
The second workshop examines how the payer environment for biosimilars is evolving. It will provide insight into pricing, reimbursement, and formulary access processes. Case studies will also be presented on successful biosimilar launches. The workshop leader is the director of RJW & Partners Ltd, a pricing and market
This document provides an agenda for the "IVD Regulatory and Strategic Forum" conference taking place on December 8-9, 2015 in Dublin, Ireland. The conference will feature keynote speakers and panels discussing topics related to in vitro diagnostic (IVD) medical device regulations, including updates on the EU's new IVD Regulation and how companies can prepare for its implementation. Specific sessions will cover issues like the role of notified bodies, clinical evidence requirements, post-market surveillance, software/mobile medical apps, and navigating regulations in different global markets. Pre-conference workshops on December 7 will address UDI implementation experiences and a pilot program for revised adverse event reporting forms.
In just over 3 weeks our Parallel Trade conference returns for its 8th year. With 9 of the top 12 pharmaceutical companies in attendance, this event is a must attend. Please check the website for the latest updated programme
3rd corporate compliance & transparency in pharmaMarket iT
This document summarizes a conference on corporate compliance and transparency in the pharmaceutical industry to be held in Zurich, Switzerland on February 25-26, 2015. The conference will address topics such as EFPIA disclosure requirements, defining transparency frameworks, preventing corruption, and challenges in emerging markets. It will feature speakers from pharmaceutical companies and industry groups. Attendees will include compliance officers, lawyers, and those involved in corporate responsibility, contracts, auditing, and business conduct.
This document provides information about the "Pharma Compliance Europe" conference taking place on October 7-8, 2015 in London. The conference will bring together senior compliance executives from pharmaceutical companies to discuss challenges in compliance, transparency, and managing relationships with healthcare professionals. It will include keynote speeches, panels, roundtable discussions, and an exhibition on topics such as developing global compliance programs, data privacy laws, monitoring practices, and culture of integrity. The event aims to help compliance professionals benchmark their strategies and programs against industry best practices.
London global transparency pc15105 brochureMarket iT
This document provides information about the "5th Annual Global Transparency Reporting Congress" conference that will take place on April 15-16, 2015 in London. The conference will focus on evolving guidelines for disclosing healthcare professional spending across the globe. It will include sessions on best practices for implementing transparency codes and managing relationships with healthcare professionals. Representatives from EFPIA, ABPI, various pharmaceutical companies, and medical organizations are scheduled to present.
This document announces a conference on evolving guidelines for disclosing healthcare professional spending across Europe. The 6th Annual Global Transparency Reporting Congress will be held on April 7-8, 2016 in Frankfurt, Germany and will feature presentations from transparency reporting professionals from various pharmaceutical companies and industry associations. The conference will provide insights on implementing disclosure guidelines and managing compliance risks related to healthcare professional payments.
This document provides information on the "Discovering the Route to Regulatory Compliance" conference taking place on September 23-24, 2015 in Barcelona, Spain. The conference will address topics related to regulatory compliance with REACH, including preparing for the 2018 registration deadline, managing substances of very high concern (SVHCs) and applications for authorization, substance and dossier evaluation, safety data sheets, and more. It lists keynote speakers from the European Chemicals Agency and industry organizations discussing these topics.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
5th Anti-Corruption and Compliance for the Oil, Gas and Extractive Industries...MarcusEvans UK
2014 Conference- Agenda & Speaker Bios
marcus evans is one of the world's leading providers and promoters of global summits strategic conferences, professional training, in-Company training, business-to-business congresses, sports hospitality and on-line information. The company also owns a leading football club, represents Hollywood stars and produces films and entertainment. To find out more about how you and your organisation can access the very best in business information, please visit us at: www.marcusevans.com
This document provides an agenda and details for the "Anti-Counterfeiting Pharma 2015" conference taking place on March 11-12, 2015 in London. The conference will feature presentations and panel discussions on topics related to anti-counterfeiting strategies in the pharmaceutical industry, including serialisation, supply chain security, legislation, mobile technologies, and tackling online pharmaceutical crime. Prominent speakers will represent organizations such as Sanofi, Shire Pharmaceuticals, MHRA, GS1, and Arnold & Porter LLP. Attendees will include professionals from R&D, supply chain, packaging, and other relevant roles within the pharmaceutical industry.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
This document is a program for the CBI Global Compliance Congress taking place November 18-19, 2015 in Munich, Germany. The program features panels and presentations on various topics related to compliance best practices from industry and government perspectives. Speakers include representatives from EFPIA, IFPMA, Transparency International, various pharmaceutical companies, and regulatory bodies such as the Serious Fraud Office. Breakout sessions will address issues like HCP relationships, third party oversight, transparency reporting, and challenges for small/mid-size compliance programs. An invitation-only CCO Summit is also included on both days.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
This document advertises an international conference on implementing the IDMP standards for pharmaceutical data. The conference will be held in Berlin in June 2015 and will provide opportunities to:
1) Learn how to assess data requirements and analyze interpretations of the IDMP standards from experts;
2) Benchmark your organization's IDMP implementation process with peers from large and mid-size pharmaceutical companies; and
3) Share insights on how the IDMP standards are changing interactions between IT systems, company functions, and regulatory agencies.
Interactive workshops and case studies from major pharmaceutical companies will also be provided. The conference aims to help companies understand, prioritize, and implement strategies to achieve seamless and fully compliant regulatory information management under the new ID
Meet GE Healthcare, Pfizer, Novartis Pharma, Boehringer-Ingelheim Pharma and ...Torben Haagh
The leading European conference on the topic of IDMP Implementation - Impact on Data, Systems and Processes is due to take place in Berlin from 24 – 25 June 2015. Don't miss your chance to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
There are now limited places available, so make sure you secure your conference ticket today! Learn more here:
http://bit.ly/_Agenda-
4th annual Pharma Anti-Counterfeiting 2015Dinesh T
4th Annual Pharma Anti-Counterfeiting 2015 taking place on 08th & 09th September 2015, London, UK
Please contact me :-Dinesh:- dinesh@virtueinsight.co.in
Fleming Europe Agenda - 3rd eMarketing PharmaHaider Alleg
The document provides information about the 3rd Annual Pharma eMarketing Congress taking place from September 11-13, 2013 in Barcelona, Spain. The event will focus on exploring new opportunities in digital marketing and how pharmaceutical companies can best leverage various e-marketing channels. It will feature expert speakers, a pre-conference social media training day, workshops, case studies, and panel discussions on topics such as social media guidelines, mobile marketing, and engaging stakeholders online. Attendees will include senior executives from marketing, communications, and digital departments of pharmaceutical companies. The event aims to provide solutions for challenges faced in e-marketing and discuss best practices for connecting with customers through new channels.
617L17_S Int Compliance, Legal Risks and Corp IntegrityHumera Akram
This document advertises the 12th Advanced Conference on International Compliance, Legal Risks and Corporate Integrity taking place January 31-February 1, 2017 in Frankfurt, Germany. The conference will bring together senior legal and compliance professionals from leading companies and enforcement agencies to discuss challenges in compliance, ethics, and risk management. New sessions at the 2017 conference will focus on anti-corruption, compliance culture, third party risks, and compliance in Latin America. Attendees can earn up to 23.25 continuing professional development credits. The conference has historically drawn over 600 attendees from 250 companies and 29 countries.
The document provides information about the 9th Pharmacovigilance Conference to be held on September 2nd, 2015 in Mumbai, India. It discusses key themes that will be covered including legislation, audits, signal detection, patient safety, and the developing regulatory framework. It outlines the agenda with topics such as PV for biologics, challenges in PV lifecycle management, and the necessary shift of sponsors and CROs from adversaries to partners. The conference aims to bring together representatives from the pharmaceutical industry and regulatory bodies to address issues in pharmacovigilance and risk management. It is intended to help attendees expand their knowledge and network with industry leaders.
SMi Group's 7th annual Biosimilars Europe 2016 conferenceDale Butler
This document provides information about two pre-conference workshops for the 7th Annual Biosimilars Europe conference.
The first workshop focuses on maximizing intellectual property and regulatory rights related to biosimilars. It will cover topics like regulatory data protection, orphan drug exclusivity, supplementary protection certificates, and pediatric rewards. The workshop leaders are partners at Bristows LLP.
The second workshop examines how the payer environment for biosimilars is evolving. It will provide insight into pricing, reimbursement, and formulary access processes. Case studies will also be presented on successful biosimilar launches. The workshop leader is the director of RJW & Partners Ltd, a pricing and market
This document provides an agenda for the "IVD Regulatory and Strategic Forum" conference taking place on December 8-9, 2015 in Dublin, Ireland. The conference will feature keynote speakers and panels discussing topics related to in vitro diagnostic (IVD) medical device regulations, including updates on the EU's new IVD Regulation and how companies can prepare for its implementation. Specific sessions will cover issues like the role of notified bodies, clinical evidence requirements, post-market surveillance, software/mobile medical apps, and navigating regulations in different global markets. Pre-conference workshops on December 7 will address UDI implementation experiences and a pilot program for revised adverse event reporting forms.
In just over 3 weeks our Parallel Trade conference returns for its 8th year. With 9 of the top 12 pharmaceutical companies in attendance, this event is a must attend. Please check the website for the latest updated programme
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Gastrointestinal Infections
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Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
PGx Analysis in VarSeq: A User’s PerspectiveGolden Helix
Since our release of the PGx capabilities in VarSeq, we’ve had a few months to gather some insights from various use cases. Some users approach PGx workflows by means of array genotyping or what seems to be a growing trend of adding the star allele calling to the existing NGS pipeline for whole genome data. Luckily, both approaches are supported with the VarSeq software platform. The genotyping method being used will also dictate what the scope of the tertiary analysis will be. For example, are your PGx reports a standalone pipeline or would your lab’s goal be to handle a dual-purpose workflow and report on PGx + Diagnostic findings.
The purpose of this webcast is to:
Discuss and demonstrate the approaches with array and NGS genotyping methods for star allele calling to prep for downstream analysis.
Following genotyping, explore alternative tertiary workflow concepts in VarSeq to handle PGx reporting.
Moreover, we will include insights users will need to consider when validating their PGx workflow for all possible star alleles and options you have for automating your PGx analysis for large number of samples. Please join us for a session dedicated to the application of star allele genotyping and subsequent PGx workflows in our VarSeq software.
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
The Children are very vulnerable to get affected with respiratory disease.
In our country, the respiratory Disease conditions are consider as major cause for mortality and Morbidity in Child.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Debunking Nutrition Myths: Separating Fact from Fiction"AlexandraDiaz101
In a world overflowing with diet trends and conflicting nutrition advice, it’s easy to get lost in misinformation. This article cuts through the noise to debunk common nutrition myths that may be sabotaging your health goals. From the truth about carbohydrates and fats to the real effects of sugar and artificial sweeteners, we break down what science actually says. Equip yourself with knowledge to make informed decisions about your diet, and learn how to navigate the complexities of modern nutrition with confidence. Say goodbye to food confusion and hello to a healthier you!
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
Corporate Compliance & Transparency in the Pharmaceutical Industry
1. Silver Sponsor: Promotional Sponsor:Lunch Sponsor:
www.fleming.events
OUR SPECIAL FEATURES
• On-Stage Interview
with EFPIA
• HCP insight • Special debate • Focused discussions
KEY BENEFITS OF ATTENDING
• Get an update on the implementation of
Disclosure Code and the first outcomes and
evaluate your implementation process
• Unravel compliance challenges relating to data
privacy
• Define Fair Market Value and develop a consistent,
simple and transparent method for your company
• Learn how to optimise interactions with HCPs
and HCOs through a fully compliant and
transparent strategy to obtain consent
• Find out compliance implications and concerns for
merging corporate cultures
• Uncover how to establish an adequate investigation
manual and procedures
4th
Annual
Corporate
Compliance
& Transparency
in the Pharmaceutical Industry
24 - 25 February 2016
Mövenpick Hotel Zürich- Regensdorf, Zürich
OUR SPEAKER PANEL
Richard Bergstrom
EFPIA | Director General
Nina Stoeckel | Merck KGaA
Director, Head of Group
Compliance Programs LE-CP
Richard Walters
GlaxoSmithKline
Head of Ethics & Compliance,
Pharma Europe
See full speaker panel on the next page
GRPTRUE DILIGENCE
2. Media Partners:
OUR SPEAKER PANEL
Nina Stoeckel | Merck KGaA
Director, Head of Group Compliance Programs LE-CP
Karl Boonen | Johnson & Johnson
Senior Director Business Practices and Compliance
EMEA & Canada
Marcela Kirberger | Sandoz
Global Compliance Officer
Christophe Lesguer | Mylan
Vice President, Chief Compliance Officer Europe
Richard Walters | GlaxoSmithKline
Head of Ethics & Compliance, Pharma Europe
Detlef Geiges | AstraZeneca | Head of Corporate
Governance/ Area Compliance Lead DE, AT, CH
Neli Nedkova | Boehringer-Ingelheim
Head of Compliance & Ethics Central and
Eastern Europe
Milena Yakimova | Actavis
Director Ethics & Compliance – Central Eastern
& South Eastern Europe
Meltem Ozker Gunduz | Novo Nordisk
Legal Affairs & Compliance Director Business
Area Near East (BANE)
Marit Pless | InterMune
European Legal Counsel, Ethical Compliance Director
Leonardo Silva | Acino Pharma AG
Head of Compliance
Maria Teresa Rico | Biogen
EU Regional Compliance Officer and JV Biosimilars
Compliance Officer
Dominique Oliver Ahnsehl
Bayer HealthCare | Compliance Counsel
Michiel Lodewijks | Roche | Compliance Officer
Richard Bergstrom | European Federation
of Pharmaceutical Industries and Associations
- EFPIA | Director General
Adrian van den Hoven | European Generic
and Biosimilar Medicines Association - EGA
Director General
Carin Smand | European Hematology
Association - EHA | Managing Director
Milada Brabcova | Eli Lilly | Compliance Director
Neeraj Singhal | MediSpend
Vice President, Product Management and Marketing
Katie Jacyna | MediSpend
Product Manager
Tim Robinson, Esq. | MediSpend
Chief Knowledge Officer / General Counsel
Nicolas Giannakopoulos | Global Risk Profile
Founding Partner
Anthony Papon | Accenture | Managing Director
Paul Melling | Baker & McKenzie | Partner
KPMG
OUR ADVISORY COMMITTEE
Esther van Weert
F. Hoffmann - La Roche
Pharma Healthcare Compliance Leader
Europe
Gian Luca Trinei
Pfizer
Chief Compliance Officer
Marit Pless
InterMune
European Legal Counsel
Milada Brabcova
Eli Lilly,
Compliance Director
Milena Yakimova
Actavis |Director Ethics & Compliance
– Central Eastern & South Eastern Europe
Hal Glasser
Former Senior Director Chief Ethics
& Compliance Officer
Sanofi Pasteur MSD
EVENT INTRODUCTION
The past decade have witnessed a wave of global transparency in the pharmaceutical industry, and 2015 has marked the start of
a new era in Europe. Companies have exerted to design and implement processes that meet spend transparency and disclosure
requirements. From 2016, pharma have to make public its payments to doctors and healthcare organisations in Europe, which is not
only a huge technical challenge, but also a major cultural shift.
This conference will serve as a platform to discuss compliance and transparency areas of key concern. Do not hesitate, take this great
networking opportunity and join us in Zürich!
Who will you meet?
CxOs, SVPs, Vps, Global heads, Heads, Directors, Officers, Counsels, Managers of Pharma/ Biotech companies responsible for
Compliance, Ethics/ Business Ethics, Legal, Regulatory Affairs, Risk Monitoring etc. Representatives of Law firms, Governmental
bodies, Audit companies, etc.
Supporting Partner:
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
3. Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor:
www.flemingeurope.com
3rd
Annual
CorPorAte
ComPliAnCe
& trAnSPArenCy
in the Pharmaceutical industry
25th
– 26th
February 2015, Zürich, Switzerland
Swissotel Zurich
Our Speaker panel:
Julie BOnhOmme,
eFpia
legal Affairs &
Compliance Deputy
Director
klauS GeldSetzer
Santen
Chief Compliance
officer europe
Ole Wendler
pederSen
nOvO nOrdiSk
General Counsel
region europe
Director legal,
Compliance &
Business Development
nick tyler
takeda
pharmaceuticalS
internatiOnal
Director Compliance
& Data Privacy
milada BraBcOva
eli lilly
Compliance Director
milena yakimOva
actaviS
Director ethics &
Compliance – Central
eastern & South
eastern europe
nader khedr
SandOz
Head regional
Compliance - meA
SanGeetha
karpOre kumar
dr. reddy‘S
laBOratOrieS
Associate Director,
Compliance Head
emerging markets
tOmaSz kruk
mallinckrOdt
pharmaceuticalS
Director international
Compliance
eSther van Weert
rOche and rOche
diaGnOSticS
Pharma Healthcare
Compliance leader
- europe
JarOSlav vaSil
Bayer
healthcare
Senior Business
Advisor
marit pleSS
intermune
internatiOnal
european legal
Counsel
dan zavOdnick
Bayer
healthcare llc
Corporate Counsel
JakuB dvOřáček
aiFp (czech
aSSOciatiOn OF
innOvative
pharmaceutical
induStry)
executive Director
rOlF Stahel
eurOpean SOciety
FOr medical
OncOlOGy (eSmO)
President
timOthy
rOBinSOn
mmiS inc./
mediSpend
Chief Knowledge
officer & General
Counsel
martiJn de
kieWit
kpmG
Head of ethics and
Compliance
management
paul mellinG
Baker & mckenzie
Partner
Geert van
GanSeWinkel
pOlariS
SOlutiOnS
managing Director
europe
Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor:
www.flemingeurope.com
3rd
Annual
CorPorAte
ComPliAnCe
& trAnSPArenCy
in the Pharmaceutical industry
25th
– 26th
February 2015, Zürich, Switzerland
Swissotel Zurich
Our Speaker panel:
Julie BOnhOmme,
eFpia
legal Affairs &
Compliance Deputy
Director
klauS GeldSetzer
Santen
Chief Compliance
officer europe
Ole Wendler
pederSen
nOvO nOrdiSk
General Counsel
region europe
Director legal,
Compliance &
Business Development
nick tyler
takeda
pharmaceuticalS
internatiOnal
Director Compliance
& Data Privacy
milada BraBcOva
eli lilly
Compliance Director
milena yakimOva
actaviS
Director ethics &
Compliance – Central
eastern & South
eastern europe
nader khedr
SandOz
Head regional
Compliance - meA
SanGeetha
karpOre kumar
dr. reddy‘S
laBOratOrieS
Associate Director,
Compliance Head
emerging markets
tOmaSz kruk
mallinckrOdt
pharmaceuticalS
Director international
Compliance
eSther van Weert
rOche and rOche
diaGnOSticS
Pharma Healthcare
Compliance leader
- europe
JarOSlav vaSil
Bayer
healthcare
Senior Business
Advisor
marit pleSS
intermune
internatiOnal
european legal
Counsel
dan zavOdnick
Bayer
healthcare llc
Corporate Counsel
JakuB dvOřáček
aiFp (czech
aSSOciatiOn OF
innOvative
pharmaceutical
induStry)
executive Director
rOlF Stahel
eurOpean SOciety
FOr medical
OncOlOGy (eSmO)
President
timOthy
rOBinSOn
mmiS inc./
mediSpend
Chief Knowledge
officer & General
Counsel
martiJn de
kieWit
kpmG
Head of ethics and
Compliance
management
paul mellinG
Baker & mckenzie
Partner
Geert van
GanSeWinkel
pOlariS
SOlutiOnS
managing Director
europe
Past Conferences in Numbers
60% Western Europe
18% Central and Eastern
Europe
16% Southern Europe
6% USA
GeographicalBreakdownNumberofAttendees
Prague 2013
Berlin 2014
Zürich 2015
Very constructive! Very well organised!
Group Corporate Governance and Compliance Officer Director, Helsinn
Very interesting and useful to hear other companies experience and learn based on this
Compliance Manager, GlaxoSmithKline
Excellent opportunity to gain knowledge and share experience
Deputy Head of Legal Affairs Division, Hemofarm
On-Stage Interview The Talk Expert Panels
Special Debate Networking Interactive App
CONFERENCE FEATURES
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
4. CONFERENCE DAY 1 | 24th
February 2016
8:30 Registration coffee
9:00 Welcoming note from Fleming.
9:05 Opening remarks from the Chair
9:10 On-stage Interview: EFPIA – Update on
Implementation of Disclosure Code
• Do‘s and don‘ts when implementing EFPIA‘s codes
• What‘s going to happen next once the data is disclosed?
• What are the challenges anticipated regarding external
communication?
• What are the challenges in specific countries related to
disclosure?
Richard Bergstrom | European Federation of
Pharmaceutical Industries and Associations - EFPIA
Director General
9:40 Transparency Obligations – Examples
of Implementation and First Outcomes
Transparency obligations are on the rise. The EFPIA Code
on Disclosures of Transfers of Value From Pharmaceutical
Companies to Healthcare Professionals and Healthcare
Organisations required reporting starting in 2016 for
2015 spend.
• Evaluation of the implementation
• A walk through of the practical implementation of
transparency processes
• Industry first observations after disclosure of data
• Country by country differences in central reporting
• Progress on managing communication with healthcare
professionals
Neli Nedkova | Boehringer-Ingelheim
Head of Compliance Ethics Central and Eastern Europe
Dominique Oliver Ahnsehl | Bayer HealthCare
Compliance Counsel
10:30 Morning coffee networking
11:00 Local Perspective: Disclosure and
Transparency Lessons Learned
Complying with the EFPIA Code on Disclosure of Transfers
of Value to Healthcare Professionals and Healthcare
Organisations will be a very complex business. This is not
least because each of the 33 countries involved has its own
slightly different approach to complying with the Code.
• Lessons learned from one location can be applied as
more associations and countries implement transparency
requirements
Michiel Lodewijks | Roche | Compliance Officer
Meltem Ozker Gunduz | Novo Nordisk | Legal Affairs
Compliance Director Business Area Near East (BANE)
Milena Yakimova | Actavis | Director Ethics
Compliance – Central Eastern South Eastern Europe
12:00 MediSpend
Topics to be announced soon
12:30 Panel Discussion
Featuring morning speakers
12:50 Lunch
hosted by
14:00 The Talk – Determining Fair Market Value
After an introduction to the topic given by one of our
speakers, participants will have the opportunity to share
their knowledge and experience. Participants will join
a table and become an active part of the discussion at
hand. To get the most out of this interactive session and
format please come prepared to share examples from your
work, share some ideas with your peers, be a part of group
discussions, and, most importantly, participate in active
idea sharing.
Fair Market Value considerations: What
does FMV matter?
• Scrutiny related to payments to HCPs
• Legitimate payments for services
• Why does FMV matter?
• Current thinking on FMV methodology
• How to monitor FMV compliance to mitigate risk of anti-
corruption violations?
• FMV Discussions
Milada Brabcova | Eli Lilly
Compliance Director
14:30 Managing Third-Party Risks – Why it
matters more than ever before
Effective compliance always comes with efficient risk
management. This session will explore how to tackle risks
posed by clients, intermediaries, suppliers, stakeholders and
other third parties and why it is not enough to simply go
through the regulator’s checklist.
• How to identify third-party risks in a complex business
environment
• Ways to manage third-party risks
• True Diligence of potential partners and existing ones
Nicolas Giannakopoulos | Global Risk Profile
Founding Partner
15:00 Collecting declarations of consent in
a cross-border environment: Possible
approaches and challenges
Neli Nedkova | Boehringer-Ingelheim
Head of Compliance Ethics Central and Eastern Europe
15:30 Data Privacy and consent management
Anthony Papon | Accenture | Managing Director
16:00 Afternoon tea networking
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
5. CONFERENCE DAY 1 | 24th
February 2016
16:20 Keynote: EGA – Code of Conduct
for European Generic and Biosimilar
Medicines Industry
• What is the EGA Code of Conduct on Interactions with
HCPs?
• What does the EGA Code understand by transparency?
• How is the EGA Code going to be implemented?
• How is the EGA Code going to be implemented in
countries where ethical codes already exist?
Adrian van den Hoven | European Generic
and Biosimilar Medicines Association - EGA
Director General
16:50 CASE STUDY: Communication and
Relationships with HCPs
• Optimising interactions with HCPs through a fully
compliant and transparency strategy
• Supporting documentation for activities and interactions
with HCPs and HCOs
• Managing consent with HCPs
Richard Walters | GlaxoSmithKline
Head of Ethics Compliance, Pharma Europe
17:20 Speak-Up Culture
Christophe Lesguer | Mylan
Vice President, Chief Compliance Officer Europe
17:50 SPECIAL DEBATE: Put Yourself in My Shoes
Our speakers from pharma industry and medical
community will get out of the comfort zone by switching
sides and, from an opposed perspective, will present
arguments to support their position in regard to their
relationship and the benefits and the hurdles of disclosure
requirements.
Carin Smand | European Hematology
Association - EHA | Managing Director
18:20 Evaluation of Day 1 closing remarks
from the Chair
Speakers and delegates are cordially
invited to attend
a Networking Cocktail Reception
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
6. CONFERENCE DAY 2 | 25th
february 2016
11:00 Morning coffee networking
11:20 Best Practices: Compliance Program
Structure and Effectiveness
• Strengthening the role of compliance within the
organisation
• Engaging with leadership to minimise the impact of
regulatory pressures on the achievement of strategic
goals
• Implementing strategic changes to manage current
and emerging risks
• Fitting anti-corruption and anti-bribery within
existing compliance, legal and other obligations
Tools available to manage internal processes
• The role of data collection in identifying risk and
exposures
Marcela Kirberger | Sandoz
Global Compliance Officer
Leonardo Silva | Acino Pharma AG
Head of Compliance
Maria Teresa Rico | Biogen | EU Regional Compliance
Officer and JV Biosimilars Compliance Officer
12:20 CASE STUDY: Compliance Implications
and Concerns for Merging Corporate
Cultures
• Challenges associated with performing due diligence
and combining compliance processes
• How to ensure due diligence post-acquisitions and
mergers
• How to align the role of internal compliance teams
in both organisations
KPMG (to be confirmed)
12:50 Lunch
hosted by
14:00 Team Structure is Critical to Success
• How to set up a compliance team to deliver on key
objectives of a compliance function
• Which capabilities are key for success
• Compliance Communication: Make Compliance
a topic for everyone and foster accountability across
the company
Nina Stoeckel | Merck KGaA
Director, Head of Group Compliance Programs LE-CP
14:30 Third Parties – Organising an Approach
for Communication, Training and
Monitoring
• Case studies on collaborating with third parties
• Which are the most common reasons that third
parties fail to meet your standards for anti-bribery
compliance?
• Comparing approaches for large, medium and small
companies
• Defining a process for qualifying third parties
• Auditing and monitoring programs to ensure
accuracy
• Managing third parties: globally, locally or by
headquarters
Paul Melling | Baker McKenzie
Partner
Karl Boonen | Johnson Johnson
Senior Director Business Practices and Compliance EMEA
Canada
15:30 Q A Discussion
15:45 Afternoon tea networking
9:00 WORKSHOP A
Managing Health Care Professional (HCP)
engagement from needs assessment to
payments
Moderators:
Neeraj Singhal | MediSpend
Vice President, Product Management and Marketing.
Katie Jacyna | MediSpend | Product Manager
Workshop Objectives:
• Key aspects and challenges faced by global
companies in engaging HCPs in a multi-country
environment
• Identify key players within the company in HCP
engagement process
• Managing international HCPs and handling the cross
boarder complexities
• Identifying the process, people, and communication
challenges within global organizations
• MediSpend’s understanding and approach to solving
this complex problem
9:00 WORKSHOP B
Building an Effective Anti-Corruption
and Anti-Bribery Program
Moderators:
Tim Robinson | MediSpend
Esq., Chief Knowledge Officer / General Counsel
Workshop Objectives:
Interactions with third-parties, including agents, distributors,
consultants and others, pose a significant risk to life science
companies. Through this workshop, participants will share
best-practices for building an effective anti-corruption
and anti-bribery program. Through this workshop and
interactive discussion, participants will gain actionable
insights and understand best-practices to benchmark
and improve their existing compliance program.
Topics to be discussed include:
• Best practices for selecting and sourcing 3rd parties
• Risk based third-party due diligence procedures
• Documenting services to be performed and related
terms
• Conducting effective training for employees and
3rd parties
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
7. 16:00 Conducting Internal Investigations
• Establishing an adequate investigation manual
and procedures
• Determining how far you should go with your
internal investigation
• Step by step internal investigation
Marit Pless | InterMune
European Legal Counsel, Ethical Compliance Director
16:30 Compliance and Risk Assessment
• Shifting from being ‚reactive‘ to risk to being
proactive about managing and mitigating risk and
execution before it becomes an issue
• Analysing data and signs to identity and prioritise risks
• Anti-corruption and anti-bribery risks: Improving
collaboration between teams to know when red flags
should be raised
• Is your anti-bribery policy a discrete, documented
process, or part of a broader policy addressing
various compliance risks?
• Company representatives‘ activities – what are the
key areas to address prior to sending personnel into
the field?
Detlef Geiges | AstraZeneca | Head of Corporate
Governance/ Area Compliance Lead DE, AT, CH
17:00 WRAP UP SESSION:
Attendees will share their findings and will be given
the opportunity to ask extra questions to speakers.
17:30 Evaluation of the conference closing
remarks from the Chair
17:35 Farewell Coffee
CONFERENCE DAY 2 | 25th
february 2016
application
Ensure that
your time at the
conference is
effective as well
as fun, with
our new online
easily accessible
networking app.
Ask questions
Vote in polls
See the up–to–date agenda
View slides in real time
and download them
Discuss topics via
the interactive wall
Network with other delegates on-line
For further information please contact:
Dasa Janosikova
Production Manager Life Sciences
Phone No.: +421 257 272 104
Email: dasa.janosikova@fleming.events
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
8. OUR SPEAKERS
Adrian van den
Hoven
European Generic and
Biosimilar Medicines
Association – EGA, Belgium
Director General
Adrian van den Hoven, joined the
European Generic and Biosimilar
medicines Association (EGA) as a Director
General in September 2013. His priorities
at the EGA are to stimulate competition
in off-patent medicine markets, to foster
market access for generic and biosimilar
medicines, to support policy measures
for sustainable pricing, to promote high
regulatory standards while ensuring that
the associated costs can be integrated
into market dynamics and to develop a
coherent EU industrial strategy to support
the long-term viability of the generic
and biosimilar medicines industry. Prior
to joining the EGA, Adrian van den
Hoven was Deputy-Director General
of BUSINESSEUROPE where he was
responsible for the International Relations
department, covering trade negotiations
and bilateral relations, and the Industry
department, covering industrial, energy,
environmental and research policy. He
previously worked as an International
Relations researcher and an adjunct
professor in Italy (EUI), France (Nice)
and Canada (Windsor). He obtained his
doctorate in Political Science from the
University of Nice, France in 2000.
Dominique Oliver
Ahnsehl
Bayer HealthCare, Germany
Compliance Counsel
Dominique Oliver Ahnsehl
is currently acting as
Compliance Counsel for Bayer
headquartersinGermany.Heisresponsible
for different compliance projects and
acting as legal and compliance support
for the transparency solution of Bayer.
Additionally, he is the business partner
for the EFPIA region and the region Asia
Pacific.
Carin Smand
European Hematology
Association - EHA,
The Netherlands
Managing Director
Since January 1, 2008 Carin
Smand has been the Managing Director
of the European Hematology Association
(EHA) which has its Executive Office in The
Hague, The Netherlands. EHA, a nonprofit
organization founded in 1992, promotes
excellence in clinical practice, research
and education in European hematology.
Since she has worked for EHA her main
focus has been to further professionalize
the organization by working towards
the development and implementation
of the association’s strategy and policy,
especially in the areas of continuous
medical education, the relationship
with pharmaceutical industry, lobbying
activities, and international collaboration.
After a 10 year career in accountancy
and tax she worked for 11 years for the
Dutch Health Care Insurance Board as
policy maker and Secretary of various
medical specialty committees, advising
the Minister of Health on the public
health care insurance system. After that
she worked as a national coordinator for
organ and tissue donation for the Dutch
Transplant Foundation.
Carin Smand studied Health Sciences
(policy and strategy) at the University of
Maastricht and Business Economics at
the Hogeschool Amsterdam (Amsterdam
University of Applied Sciences).
Detlef Geiges
AstraZeneca, Germany
Head of Corporate
Governance/Area Compliance
Lead DE, AT, CH
Detlef currently holds
a position of Compliance Area Lead
GE, AT, CH and is responsible for the
compliance leadership in the respective
area and contribution to ECLT and several
regional/global projects. Since 2011, he
became Head of Corporate Governance,
member of SMT at AstraZeneca, where
he gained extensive experience in
compliance business partnering and
assurance, including compliance support
and advice, maintenance of governance
assurance framework of monitoring,
auditing, incident management, training,
as well as in financial controls framework
and risk crisis management.
Detlef started his professional career at
Clinserve Clinical Trial Services in 1996
and joined AstraZeneca Germany Medical
Department in 1998. Between 1998
and 2011, Detlef went through various
positions with increasing responsibilities
in clinical research operations.
Detlef studied Biology at the University
of Freiburg and completed his PhD in
cellular biology/signal transduction
at German Cancer Research Center,
Heidelber in 1995.
Richard Bergstrom
European Federation of
Pharmaceutical Industries
and Associations - EFPIA,
Belgium
Director General
Richard Bergström has been the Director
General of the European Federation
of Pharmaceutical Industries and
Associations (EFPIA) since April 2011.
Previously he served for nine years as
the Director-General of LIF, the Swedish
AssociationofthePharmaceuticalIndustry,
following positions in Switzerland in
regulatory affairs at the pharmaceutical
companies Roche and Novartis. Mr
Bergström was also appointed by the
Swedish Government to the Board of the
Karolinska Institute. He is a pharmacist by
training, receiving his MScPharm degree
from the University of Uppsala, Sweden
in 1988.
Richard Walters
GlaxoSmithKline, UK
Head of Ethics Compliance,
Pharma Europe
Dr Richard Walters is Head
of Ethics Compliance
for Pharma Europe Canada at
GlaxoSmithKline, based in London. In
his role Richard leads a team of over
70 compliance professionals and is
a member of GSK’s Global Ethics
Compliance Leadership team. Richard
joined GSK in 2005, following the
completion of his DPhil studies in
Pharmacology at Oxford University,
where he has held roles of increasing
responsibility within RD, Regulatory
Affairs, Scientific Communications,
Medical Affairs, Corporate Strategy
within the CEO’s office and Commercial
Operations; during this time he has been
located in the UK, France, India and
Spain. Richard is a current member of
EFPIA’s Ethics Compliance Committee,
a certified Leading Professional in Ethics
and Compliance (LPEC) and has an MBA
from Warwick University Business School.
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
9. Karolina
Czernicka-Kuhl
Novo Nordisk, Poland
Head of Legal and Compliance
Europe East
Karolina Czernicka-Kuhl,
is heading the Novo Nordisk Legal
Compliance function in Europe East,
covering 17 countries. Prior to joining
Novo Nordisk, Karolina worked for over
12 years at Linklaters (a leading global
law firm) in Warsaw and London focusing
mainly on mergers and acquisitions, as
well as investment funds management.
She holds a master degree in law from the
University of Warsaw, Poland and L.LM
from University of Münster, Germany.
Karolina is an attorney-at-law for Poland
and a solicitor for England and Wales.
Leonardo Silva
Acino Pharma AG,
Switzerland
Head of Compliance
Leonardo Silva heads Acino’s
Compliance department
globally, based out of the company’s
global HQ in Basel, Switzerland. Prior
to that, Leonardo worked for Takeda
Pharmaceuticals in both Brazil and in
Switzerland’s International hub, covering
the development, implementation
training on Policies and SOPs in 40+
Emerging Markets.
Prior to Takeda, Leonardo worked for
Merck, Sharp Dohme (MSD) (formerly
Schering-Plough/Organon) in Brazil and
select LATAM operations such as Central
America, and north South America, as well
as multiple secondments to the global law
department in NJ, USA.
He holds a master degree in law from the
London School of Economics and Political
Science – LSE - University of London
and is a licensed attorney-at-law for the
jurisdiction of Brazil.
Meltem Ozker
Gunduz
Novo Nordisk, Turkey
Legal Affairs Compliance
Director Business Area
Near East (BANE)
Meltem Ozker Gunduz, born in Turkey,
based in Istanbul. Graduated from
Galatasaray University Law Faculty. Her
LL.M studies are ongoing in Istanbul
University with focus on Employment
Law. Worked in Istanbul and London
Offices of Herguner Bilgen Ozeke Attorney
Partnership until 2010, after then joined
Novo Nordisk Business Area Near East in
2010 with responsibility for managing
legal and compliance issues in Turkey,
Iran, Iraq, Israel, Jordan, Lebanon, Syria,
Pakistan, Afghanistan, Ukraine and
Moldova. She is currently Legal Affairs
Compliance Director in Novo Nordisk
Business Area Near East and she speaks
Turkish, English and French.
Milada Brabcova
Eli Lilly
Compliance Director
Milada Brabcova has been a
Compliance Director for the
Czech Republic and Slovakia
in Eli Lilly since 2007. In
her role she leads an implementation of
the compliance programme with the
main focus on ethical interactions, anti-
corruption and privacy. As a member
of Compliance and Transparency
Working Groups in the Czech and Slovak
Industry Associations (AIFP) she has been
involved in a local implementation of
EFPIA transparency disclosures. Milada
has 18 years of experience working in
the pharmaceutical industry in several
positions including sales and marketing as
a National Sales Manager, Eli Lilly Czech
Republic. Milada graduated as a Master in
Biology and Chemistry and subsequently
obtained a Doctoral Degree in Natural
Science at Charles University in Prague.
She holds a Master Degree in Business
Administration (MBA) from the Open
University Business School in the United
Kingdom (Milton Keynes).
Marcela Kirberger
Sandoz, Germany
Global Head of Compliance
Marcela was appointed
Global Head of Compliance
reporting operationally to
Shannon Thyme Klinger and functionally
to Eric Cornut, Chief Ethics, Compliance
and Policy Officer in July of 2014. Marcela
is based in Holzkirchen, Germany and is a
member of the Sandoz Legal Leadership
Team (SLLT) and the Compliance
Leadership Team (CLT). In this position,
Marcela is responsible for managing and
coordinating all integrity and compliance
matters for Sandoz globally.
Marcela joined Novartis in 2006 and has
worked for different Novartis divisions
since, assuming positions of increasing
responsibility. In 2012, she assumed the
position of Lead Counsel to the Primary
Care and Established Medicines Business
Unit at NPC (Novartis Pharmaceuticals
Corporation) where she provided legal
advice for all BU matters. Before joining
Novartis, Marcela was a Securities litigator
at Lowenstein Sandler in New Jersey and
prior to that she held a judicial clerkship
for the New Jersey Appellate Division.
Marcela was born in Buenos Aires,
Argentina and received a law degree from
the Catholic University of Argentina and
later a law degree from the Rutgers School
of Law in Newark, New Jersey.
Milena Yakimova
Actavis, Bulgaria
Director Ethics Compliance – Central Eastern
South Eastern Europe
Milena holds a law degree from London
School of economics, Strasbourg
University and a post – graduate degree in
law from College of Europe, Bruges.
Currently Milena is a Director Ethics and
compliance at Actavis with responsibility
for managing the compliance program
within the European region. She has an
experience as a lawyer with the white
collar defense and antitrust practices of
US law firms, based in Brussels. Milena has
extensively advised on the application of
EU competition and regulatory law to the
pharmaceutical sector, on the interplay
between antitrust and intellectual
property law and on how to comply with
the Data Protection Act when transferring
data overseas. She has also served as a
legal officer at the Bulgarian competition
authority.
Neli Nedkova
Boehringer-Ingelheim, Austria
Head of Compliance Ethics
Central and Eastern Europe
Dr. Neli Nedkova is
currently Head of
Compliance Ethics Central and
Eastern Europe. She is responsible for the
implementation of the Group’s corporate
compliance program and development,
implementation and monitoring of the
regional compliance program for the
CEE Region (19 countries): including
establishing respective governance
structures, performing risk assessment
and due diligence, developing policies
and procedures, performing training
and creating awareness, conducting
program monitoring and internal
investigations. She also coordinates the
network of subject-matter experts and
local compliance officers in the region
and provides guidance and advice to
the management and all functions. She
is a Member of the Global Compliance
Leadership Team and Global Subject
Matter Expert for Anti-corruption.
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events
10. Nina Stoeckel
Merck KGaA, Germany
Director, Head of Group
Compliance Programs LE-CP
Nina is currently Director
Global Compliance
Program, where she is responsible for
strategicdevelopmentandimplementation
of the effective Compliance program
and organization for all business sectors
of the Merck companies, as well as for
the maintenance of the Compliance
framework and conducting complex
Compliance projects. Between 2009
and 2014, she held variety of positions
with the increasing responsibilities in the
ethics and compliance area at Boehringer
Ingelheim. Nina started her professional
career in 2000 as an In-house lawyer
and project manager at Media-Group
Suddeutscher Verlag, where she became a
member of the compliance team in 2007.
Nina completed her Law studies at
Ruprecht-Karls-Universitat Heidelberg,
Germany in 1998. In 2008, she gained
her Master of Laws, completing her
postgraduate studies “International
Business Law” at the University of Applied
Sciences Mainz.
Nicolas
Giannakopoulos
Global Risk Profile,
Switzerland
Founding Partner
Nicolas Giannakopoulos is
an internationally recognized expert in
crime-related issues, including criminal
risks inherent to the public and private
sectors.
After completing a MA in Political
Science from University of Geneva, Mr.
Giannakopoulos has carried out numerous
research projects on behalf of large
institutions.
He was notably in charge of a three-year
research program on corruption and
organized crime in Switzerland, financed
by the Swiss Confederation.
In 2010, Mr. Giannakopoulos cofounded
Global Risk Profile – a Swiss company
providing Due diligence services.
Lecturer at the University of Geneva, he
is regularly called upon to intervene in
various conferences, some at a ministerial
level.
Paul Melling
Baker McKenzie
Partner
Paul Melling is an English
solicitor and the founding
partner of Baker
McKenzie’s Moscow office (he is also
founding partner of the Firm’s Almaty
office).He first joined Baker McKenzie’s
London office in February 1980, as
a member of the Firm’s East-West
Trade Department, specializing in the
COMECON countries of Eastern Europe
and particularly the USSR. He took up
residence in Moscow in January, 1989 and
has spent over 27 years as a partner in the
CIS.
Mr. Melling is the founder of and leads
the pharmaceuticals and healthcare
industry practice in Russia/CIS and is
a Steering Committee member of the
Firm’s Global and EMEA Pharmaceuticals/
Healthcare Practice Groups. For 22 years
he has been Honorary Legal Adviser in
Russia to the Association of International
Pharmaceuticals Manufacturers (AIPM).
He has also been the Honorary Legal
Adviser to the British Ambassador in
Moscow since 1990.and is a member of
the Advisory Council of the Russo-British
Chamber of Commerce.
Mr. Melling also leads the compliance
practice in the Firm’s CIS offices and is a
Steering Committee member of the Firm’s
European Compliance Practice Group. He
is a member of the International Business
Leaders Forum’s International Advisory
Council for Russia and a member of the
Leadership Group for IBLF’s “Improving
Business Standards in Russia Initiative”.
In 2013 he was appointed to Russia’s B
20 Task Force on Transparency and Anti-
Corruption.
In 2009 Mr. Melling received the
Distinguished Service Award from
AIPM for “Outstanding Contribution
to the Development of the Russian
Pharmaceuticals Market”.
Booking line: tel: +421 257 272 155, fax: 421 255 644 490
email: lesly.solei@fleming.events, www.fleming.events