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Monitoring forum

Haider Alleg
Haider Alleg

The document discusses how pharmaceutical companies can manage online adverse events. It outlines a process for monitoring social media and other online sources to detect adverse event mentions related to a company's products. Key aspects of the proposed process include setting up global and local monitoring teams, using a tool like Radarly to capture mentions, qualifying posts according to a response grid, and reporting any potential adverse events to pharmacovigilance teams within 24 hours. The goal is to have a structured yet adaptable process that allows companies to monitor online conversations and respond appropriately to any safety issues.

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Online monitoring process How to manage online adverse events within pharmaceutical players? Haider Alleg Global eMarketing Manager Munich - 06.02.2013
About this presentation Why using social media listening and monitoring to impact Esmya速 digital strategy? How to structure as a global pharmaceutical company to handle social media mentions? How to setup a robust social media process both at a global and local scale? How to handle online adverse events as an international team? Online monitoring process | Haider Alleg 2 Munich (06.02.2013)
About Gedeon Richter and Esmya速 Development of generic drugs and chemical processes as well A Pan-European specialty pharmaceutical company as biotechnology A 112 year old company present in more than thirty countries An expanding product portfolio Online monitoring process | Haider Alleg 3 Munich (06.02.2013)
About Gedeon Richter and Esmya速 Online monitoring process | Haider Alleg 4 Munich (06.02.2013)
About me Gedeon Richter Global eMarketing Manager (Geneva) 27 years old, 10 years working in the digital industry 2 master degrees: International Marketing and Business /*Digital worker since 2003*/ Administration 5 years in the healthcare industry and global projects (Novartis, Roche, Pfizer, NovoNordisk, Medtronic...) e-insights mining, social media campaigns, performance campaigns, metrics and dash-boarding... Online monitoring process | Haider Alleg 5 Munich (06.02.2013)
Context Esmya速 launched in Europe since 2012 (present in UK, DE and some CEE countries, others to follow soon) Online monitoring process | Haider Alleg 6 Munich (06.02.2013)
Context Esmya速 digital strategy is a core DNA branch of the brand plan Measuring Esmya@ brand impact on corporate image (Biotech drug vs. Generics) Engaging with doctors (gynecologists, surgeons and pathologists) Help patients put a name on a condition (disease awareness strategy) Online monitoring process | Haider Alleg 7 Munich (06.02.2013)
Context Gedeon Richter (GR) is structuring digital activities globally and locally Listening to know where to act and which content strategy to adopt Defining a process globally and improve our efficiency locally Engage in social media from a corporate, patients and doctors angle Online monitoring process | Haider Alleg 8 Munich (06.02.2013)
Listening to diagnostic and build the e-strategy E-insights mining (qualitative) E-monitoring (quantitative) Online monitoring process | Haider Alleg 9 Munich (06.02.2013)
Step 1. Take a snapshot Online monitoring process | Haider Alleg 10 Munich (06.02.2013)
Listening to diagnostic and build the e-strategy 2 pilot studies in German and English, with focus in the UK and Germany 2 months of research, humanized approach (native speakers) Verbatim based on the disease keywords, Esmya速 and Gedeon Richter mentions Online monitoring process | Haider Alleg 11 Munich (06.02.2013)
Listening to diagnostic and build the e-strategy Objectives of the study: a fly on the wall Who is speaking? Profile of talkers. Where are nodes of communication around the product, the disease? Where are KOLs? What is the reputation of the drug? The lab? Among patients? Among doctors? What are the topics? Why? How to engage with them? Where are potential adverse events? Online monitoring process | Haider Alleg 12 Munich (06.02.2013)
Listening to diagnostic and build the e-strategy Online monitoring process | Haider Alleg 13 Munich (06.02.2013)
Listening to diagnostic and build the e-strategy Online monitoring process | Haider Alleg 14 Munich (06.02.2013)
Step 2. Establish the digital strategy Online monitoring process | Haider Alleg 15 Munich (06.02.2013)
Key takeaways for Esmya速 digital strategy Online monitoring process | Haider Alleg 16 Munich (06.02.2013)
Step 3. Take the pulse Online monitoring process | Haider Alleg 17 Munich (06.02.2013)
Monitoring tools market Existing solutions are either: Not easy to setup Not easy to scale Not easy to use Not cheap! Too technical Not adapted Online monitoring process | Haider Alleg 18 Munich (06.02.2013)
Monitoring tools market Online monitoring process | Haider Alleg 19 Munich (06.02.2013)
Setup the monitoring to answer business goals We setup Radarly at a global level to measure in all markets: Brand mentions Event impact Marketing campaigns impact Uterine fibroids discussions KOLs exposure Adverse events Scientific publications Online monitoring process | Haider Alleg 20 Munich (06.02.2013)
Step 4. Structure Online monitoring process | Haider Alleg 21 Munich (06.02.2013)
Setup the monitoring to answer business goals Medical/ ≒Prepare the verbatim marketing PV/ ≒Review and training updates Regulatory ≒Implementation of English eMarketing (global) verbatim Local ≒Adapt global Medical/ verbatim to local market Marketing Local PV/ ≒Review local verbatim Regulatory Online monitoring process | Haider Alleg 22 Munich (06.02.2013)
Monitoring process structure: Think global, act local Radarly captures mentions in the global dashboard y da AU n/ TO mi 20 Local native speakers Global eMarketer qualify the posts in 1h / day assigned posts to local English (Marketer/PV) native speakers Online monitoring process | Haider Alleg 23 Munich (06.02.2013)
Monitoring process structure: Think global, act local Decentralised Clustered Centralised at the HQ Online monitoring process | Haider Alleg 24 Munich (06.02.2013)
Monitoring process stakeholders RH Innovation Marketing Corporate Events Coms Key stakeholders Digital Social PR media are required for monitoring success Legal process IT Sales PV Med Marketing Regulatory Med Info Online monitoring process | Haider Alleg 25 Munich (06.02.2013)
Monitoring tool box: Response grid and criticality matrix Online Monitoring One to one One to Many Criticality Response Contact KOLs list matrix grid plan Online monitoring process | Haider Alleg 26 Munich (06.02.2013)
Monitoring tool box: Response grid and criticality matrix 3 levels of content interactions White, green, red list content, where designed employee and external agency can answer based on a list of predefined answers Grey list, updated as soon as a new topic, question pops up on a social media support by experts Black list, where the DEFCON mode may be activated with a proactive and protective answer. Online monitoring process | Haider Alleg 27 Munich (06.02.2013)
Monitoring tool box: Response grid and criticality matrix Online monitoring process | Haider Alleg 28 Munich (06.02.2013)
Monitoring tool box: Response grid and criticality matrix Criticality = Detectability X Severity X Frequency Monitoring and qualifying posts in Radarly help us track a common KPI and to take quick decisions Online monitoring process | Haider Alleg 29 Munich (06.02.2013)
Monitoring tool box: Response grid and criticality matrix Response grid Each posts collected and qualified (White, Green, Red...) is associated with a pre-defined action or message in a database updated globally. Helps keep a unique voice and tonality. Anticipate and solve potential crisis with the crisis committee. Online monitoring process | Haider Alleg 30 Munich (06.02.2013)
Step 5. Adapt Online monitoring process | Haider Alleg 31 Munich (06.02.2013)
Definition of an adverse event reaction Adverse Event (or Adverse Experience) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Source: http://www.emea.europa.eu/docs/en_GB/document_library/Scienti鍖c_guideline/2009/09/WC500002749.pdf Online monitoring process | Haider Alleg 32 Munich (06.02.2013)
Obligations as a pharma player New Guideline on good pharmacovigilance practices published on 2nd July 2012 Two scenarios: 1. Digital media company sponsored. 2. Digital media not company sponsored. How is defined company sponsored? if it is owned, paid for and/or controlled by the Market Authorization Holder Note: a donation (financial or otherwise) to an organization/site by a Market Authorization Holder does not constitute ownership, provided that the MAH does not control the final content of the site. Source: Internal PV Online monitoring process | Haider Alleg 33 Munich (06.02.2013)
How to react vs. an adverse event? 1. The adverse event is collected by Radarly 2. A team member is qualifying it under the potential AE category on a defined time screening (e.g. 10 minutes every day) 3. An email is sent within 24h to local PV if one or multiple AEs are detected during the screening 4. PV asses if this is an actual AE (association with the drug, drug potential side effects, possibility of contacting the patient...) 5. If the AEs is valid, PV is reporting it as any other AEs coming from other channel. Source: ABPI - UK Online monitoring process | Haider Alleg 34 Munich (06.02.2013)
Next steps for Gedeon Richter Follow and adjust Esmya速 digital plan for 2013-15 Continue the integration of new brand teams and countries in the global monitoring activity Continue training more and more colleagues locally to expand our capability of absorbing mentions qualification Online monitoring process | Haider Alleg 35 Munich (06.02.2013)
Thank You! Online monitoring process | Haider Alleg 36 Munich (06.02.2013)
Appendix Online monitoring process | Haider Alleg 37 Munich (06.02.2013)
Obligations as a pharma player Digital media company sponsored The company should regularly screen it for potential reports of suspected adverse reactions. Frequency of the screening should allow for potential valid cases to be reported on time to the Authorities based on the date the information was posted on the media: At a minimum, regular screening every two/ three days. Clear process should be in place to report this case (valid or non-valid) to the local PV Officer within 24 hours. Obligation to screen for adverse reactions and any cases of lack of efficacy, misuse, overdose, abuse, off- label use, pregnancy, breastfeeding Source: Internal PV Online monitoring process | Haider Alleg 38 Munich (06.02.2013)
Obligations as a pharma player Digital media non company sponsored (ex: forum) If the company becomes aware of a report of suspected adverse reaction, it should be assessed and handled as a spontaneous report. Day 0 is not the day of posting but the day one Gedeon Richter employee becomes aware of the report. No regular screening is requested. Clear process should be in place to report this case (valid or non-valid) to the local PV Officer within 24 hours. No obligation to screen for adverse reactions and any cases of lack of efficacy, misuse, overdose, abuse, off-label use, pregnancy, breastfeeding Source: Internal PV Online monitoring process | Haider Alleg 39 Munich (06.02.2013)
Crisis Process Core task force prepared in case (PR, IT, Legal, Marketing...) Quick response on situations even locally (same platform) Anticipate by learning before acting online Avoid crisis by adapting the right messages to the right audience through the right channel Online monitoring process | Haider Alleg 40 Munich (06.02.2013)
Agenda 10. Monitoring process structure: Think global, act 1. About this presentation local 2. About Gedeon Richter and Esmya速 11. Monitoring process stakeholders 3. About me 12. Monitoring tool box: Response grid and criticality matrix 4. Context 13. Crisis process 5. Listening to diagnostic and build e-strategy 14. Definition of an adverse event reaction 6. Why listening using insights mining? 15. Obligations as a pharma player 7. Key takeaways for Esmya速 digital strategy 16. How to react vs. an adverse event? 8. Monitoring tools market 17. Next steps for Gedeon Richter 9. Setup the monitoring to answer business goals 18. Questions Online monitoring process | Haider Alleg 41 Munich (06.02.2013)

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Monitoring forum

  • 1. Online monitoring process How to manage online adverse events within pharmaceutical players? Haider Alleg Global eMarketing Manager Munich - 06.02.2013
  • 2. About this presentation Why using social media listening and monitoring to impact Esmya速 digital strategy? How to structure as a global pharmaceutical company to handle social media mentions? How to setup a robust social media process both at a global and local scale? How to handle online adverse events as an international team? Online monitoring process | Haider Alleg 2 Munich (06.02.2013)
  • 3. About Gedeon Richter and Esmya速 Development of generic drugs and chemical processes as well A Pan-European specialty pharmaceutical company as biotechnology A 112 year old company present in more than thirty countries An expanding product portfolio Online monitoring process | Haider Alleg 3 Munich (06.02.2013)
  • 4. About Gedeon Richter and Esmya速 Online monitoring process | Haider Alleg 4 Munich (06.02.2013)
  • 5. About me Gedeon Richter Global eMarketing Manager (Geneva) 27 years old, 10 years working in the digital industry 2 master degrees: International Marketing and Business /*Digital worker since 2003*/ Administration 5 years in the healthcare industry and global projects (Novartis, Roche, Pfizer, NovoNordisk, Medtronic...) e-insights mining, social media campaigns, performance campaigns, metrics and dash-boarding... Online monitoring process | Haider Alleg 5 Munich (06.02.2013)
  • 6. Context Esmya速 launched in Europe since 2012 (present in UK, DE and some CEE countries, others to follow soon) Online monitoring process | Haider Alleg 6 Munich (06.02.2013)
  • 7. Context Esmya速 digital strategy is a core DNA branch of the brand plan Measuring Esmya@ brand impact on corporate image (Biotech drug vs. Generics) Engaging with doctors (gynecologists, surgeons and pathologists) Help patients put a name on a condition (disease awareness strategy) Online monitoring process | Haider Alleg 7 Munich (06.02.2013)
  • 8. Context Gedeon Richter (GR) is structuring digital activities globally and locally Listening to know where to act and which content strategy to adopt Defining a process globally and improve our efficiency locally Engage in social media from a corporate, patients and doctors angle Online monitoring process | Haider Alleg 8 Munich (06.02.2013)
  • 9. Listening to diagnostic and build the e-strategy E-insights mining (qualitative) E-monitoring (quantitative) Online monitoring process | Haider Alleg 9 Munich (06.02.2013)
  • 10. Step 1. Take a snapshot Online monitoring process | Haider Alleg 10 Munich (06.02.2013)
  • 11. Listening to diagnostic and build the e-strategy 2 pilot studies in German and English, with focus in the UK and Germany 2 months of research, humanized approach (native speakers) Verbatim based on the disease keywords, Esmya速 and Gedeon Richter mentions Online monitoring process | Haider Alleg 11 Munich (06.02.2013)
  • 12. Listening to diagnostic and build the e-strategy Objectives of the study: a fly on the wall Who is speaking? Profile of talkers. Where are nodes of communication around the product, the disease? Where are KOLs? What is the reputation of the drug? The lab? Among patients? Among doctors? What are the topics? Why? How to engage with them? Where are potential adverse events? Online monitoring process | Haider Alleg 12 Munich (06.02.2013)
  • 13. Listening to diagnostic and build the e-strategy Online monitoring process | Haider Alleg 13 Munich (06.02.2013)
  • 14. Listening to diagnostic and build the e-strategy Online monitoring process | Haider Alleg 14 Munich (06.02.2013)
  • 15. Step 2. Establish the digital strategy Online monitoring process | Haider Alleg 15 Munich (06.02.2013)
  • 16. Key takeaways for Esmya速 digital strategy Online monitoring process | Haider Alleg 16 Munich (06.02.2013)
  • 17. Step 3. Take the pulse Online monitoring process | Haider Alleg 17 Munich (06.02.2013)
  • 18. Monitoring tools market Existing solutions are either: Not easy to setup Not easy to scale Not easy to use Not cheap! Too technical Not adapted Online monitoring process | Haider Alleg 18 Munich (06.02.2013)
  • 19. Monitoring tools market Online monitoring process | Haider Alleg 19 Munich (06.02.2013)
  • 20. Setup the monitoring to answer business goals We setup Radarly at a global level to measure in all markets: Brand mentions Event impact Marketing campaigns impact Uterine fibroids discussions KOLs exposure Adverse events Scientific publications Online monitoring process | Haider Alleg 20 Munich (06.02.2013)
  • 21. Step 4. Structure Online monitoring process | Haider Alleg 21 Munich (06.02.2013)
  • 22. Setup the monitoring to answer business goals Medical/ ≒Prepare the verbatim marketing PV/ ≒Review and training updates Regulatory ≒Implementation of English eMarketing (global) verbatim Local ≒Adapt global Medical/ verbatim to local market Marketing Local PV/ ≒Review local verbatim Regulatory Online monitoring process | Haider Alleg 22 Munich (06.02.2013)
  • 23. Monitoring process structure: Think global, act local Radarly captures mentions in the global dashboard y da AU n/ TO mi 20 Local native speakers Global eMarketer qualify the posts in 1h / day assigned posts to local English (Marketer/PV) native speakers Online monitoring process | Haider Alleg 23 Munich (06.02.2013)
  • 24. Monitoring process structure: Think global, act local Decentralised Clustered Centralised at the HQ Online monitoring process | Haider Alleg 24 Munich (06.02.2013)
  • 25. Monitoring process stakeholders RH Innovation Marketing Corporate Events Coms Key stakeholders Digital Social PR media are required for monitoring success Legal process IT Sales PV Med Marketing Regulatory Med Info Online monitoring process | Haider Alleg 25 Munich (06.02.2013)
  • 26. Monitoring tool box: Response grid and criticality matrix Online Monitoring One to one One to Many Criticality Response Contact KOLs list matrix grid plan Online monitoring process | Haider Alleg 26 Munich (06.02.2013)
  • 27. Monitoring tool box: Response grid and criticality matrix 3 levels of content interactions White, green, red list content, where designed employee and external agency can answer based on a list of predefined answers Grey list, updated as soon as a new topic, question pops up on a social media support by experts Black list, where the DEFCON mode may be activated with a proactive and protective answer. Online monitoring process | Haider Alleg 27 Munich (06.02.2013)
  • 28. Monitoring tool box: Response grid and criticality matrix Online monitoring process | Haider Alleg 28 Munich (06.02.2013)
  • 29. Monitoring tool box: Response grid and criticality matrix Criticality = Detectability X Severity X Frequency Monitoring and qualifying posts in Radarly help us track a common KPI and to take quick decisions Online monitoring process | Haider Alleg 29 Munich (06.02.2013)
  • 30. Monitoring tool box: Response grid and criticality matrix Response grid Each posts collected and qualified (White, Green, Red...) is associated with a pre-defined action or message in a database updated globally. Helps keep a unique voice and tonality. Anticipate and solve potential crisis with the crisis committee. Online monitoring process | Haider Alleg 30 Munich (06.02.2013)
  • 31. Step 5. Adapt Online monitoring process | Haider Alleg 31 Munich (06.02.2013)
  • 32. Definition of an adverse event reaction Adverse Event (or Adverse Experience) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Source: http://www.emea.europa.eu/docs/en_GB/document_library/Scienti鍖c_guideline/2009/09/WC500002749.pdf Online monitoring process | Haider Alleg 32 Munich (06.02.2013)
  • 33. Obligations as a pharma player New Guideline on good pharmacovigilance practices published on 2nd July 2012 Two scenarios: 1. Digital media company sponsored. 2. Digital media not company sponsored. How is defined company sponsored? if it is owned, paid for and/or controlled by the Market Authorization Holder Note: a donation (financial or otherwise) to an organization/site by a Market Authorization Holder does not constitute ownership, provided that the MAH does not control the final content of the site. Source: Internal PV Online monitoring process | Haider Alleg 33 Munich (06.02.2013)
  • 34. How to react vs. an adverse event? 1. The adverse event is collected by Radarly 2. A team member is qualifying it under the potential AE category on a defined time screening (e.g. 10 minutes every day) 3. An email is sent within 24h to local PV if one or multiple AEs are detected during the screening 4. PV asses if this is an actual AE (association with the drug, drug potential side effects, possibility of contacting the patient...) 5. If the AEs is valid, PV is reporting it as any other AEs coming from other channel. Source: ABPI - UK Online monitoring process | Haider Alleg 34 Munich (06.02.2013)
  • 35. Next steps for Gedeon Richter Follow and adjust Esmya速 digital plan for 2013-15 Continue the integration of new brand teams and countries in the global monitoring activity Continue training more and more colleagues locally to expand our capability of absorbing mentions qualification Online monitoring process | Haider Alleg 35 Munich (06.02.2013)
  • 36. Thank You! Online monitoring process | Haider Alleg 36 Munich (06.02.2013)
  • 37. Appendix Online monitoring process | Haider Alleg 37 Munich (06.02.2013)
  • 38. Obligations as a pharma player Digital media company sponsored The company should regularly screen it for potential reports of suspected adverse reactions. Frequency of the screening should allow for potential valid cases to be reported on time to the Authorities based on the date the information was posted on the media: At a minimum, regular screening every two/ three days. Clear process should be in place to report this case (valid or non-valid) to the local PV Officer within 24 hours. Obligation to screen for adverse reactions and any cases of lack of efficacy, misuse, overdose, abuse, off- label use, pregnancy, breastfeeding Source: Internal PV Online monitoring process | Haider Alleg 38 Munich (06.02.2013)
  • 39. Obligations as a pharma player Digital media non company sponsored (ex: forum) If the company becomes aware of a report of suspected adverse reaction, it should be assessed and handled as a spontaneous report. Day 0 is not the day of posting but the day one Gedeon Richter employee becomes aware of the report. No regular screening is requested. Clear process should be in place to report this case (valid or non-valid) to the local PV Officer within 24 hours. No obligation to screen for adverse reactions and any cases of lack of efficacy, misuse, overdose, abuse, off-label use, pregnancy, breastfeeding Source: Internal PV Online monitoring process | Haider Alleg 39 Munich (06.02.2013)
  • 40. Crisis Process Core task force prepared in case (PR, IT, Legal, Marketing...) Quick response on situations even locally (same platform) Anticipate by learning before acting online Avoid crisis by adapting the right messages to the right audience through the right channel Online monitoring process | Haider Alleg 40 Munich (06.02.2013)
  • 41. Agenda 10. Monitoring process structure: Think global, act 1. About this presentation local 2. About Gedeon Richter and Esmya速 11. Monitoring process stakeholders 3. About me 12. Monitoring tool box: Response grid and criticality matrix 4. Context 13. Crisis process 5. Listening to diagnostic and build e-strategy 14. Definition of an adverse event reaction 6. Why listening using insights mining? 15. Obligations as a pharma player 7. Key takeaways for Esmya速 digital strategy 16. How to react vs. an adverse event? 8. Monitoring tools market 17. Next steps for Gedeon Richter 9. Setup the monitoring to answer business goals 18. Questions Online monitoring process | Haider Alleg 41 Munich (06.02.2013)