Private&Sector&Collaboraon& with&Naonal&Regulatory&Systems&€¦ · Private sector collaboration...

Annual ISoP Meeting | Geneva 2018.11.12 Private sector collaboration with National Regulatory Systems | J. Christophe Delumeau 1

Annual ISoP Mee-ng 2018 | Geneva 2018.11.12 Private Sector Collabora-on with Na-onal Regulatory Systems Asia-‐Pacific & China Eurasian Economic Union Simplifying and Improving Global ICSR Submission

J. Christophe Delumeau


J. Christophe Delumeau, MD, PhD •  Full-‐-me employee of Bayer South East Asia (Singapore) as head of pharmacovigilance policy strategy. •  Not holding any stock op-on. •  Not holding any share of any pharma nor health care company. •  Not receiving any consul-ng fees or grants. •  Receiving no compensa-on for serving as Board and Execu-ve CommiUee member of the Interna-onal Society of

Pharmacovigilance (ISoP). •  Receiving no compensa-on for serving the chair or co-‐chair of working groups or ini-a-ves of the Interna-onal of

the European Federa-on of Pharmaceu-cal Industries and Associa-ons (EFPIA).

•  Receiving no compensa-on for serving as Visi-ng Expert at Duke-‐NUS university, Singapore. •  The views expressed in this presenta-on reflect the personal views of the author and do not necessarily reflect the

views of the authors’ employers (Bayer) nor ISoP, nor EFPIA, nor any other ins-tu-ons the author may otherwise be collabora-ng with.

Disclaimer and declara-on of conflicts of interest


•  EAEU: Eurasian Economic Union •  EFPIA: European Federa-on of Pharmaceu-cal Industries and Associa-ons •  EFPIA-‐IPVG: EFPIA Interna-onal PV Global Team •  EFPIA-‐IPV-‐WS: EFPIA Interna-onal PV (regional) Work-‐Stream •  HCP: Health Care Professionals •  HCS: Health Care System •  ICH: Interna-onal Council for Harmonisa-on of Technical Requirements for Pharmaceu-cals for Human

Use •  ICH-‐E2B (ICH standard for ICSR data transmission •  ICSR: Individual Case Safety Reports •  NRA: Na-onal Regulatory Authority •  NRS: Na-onal Regulatory System •  MAH: Market Authorisa-on Holder •  PV: Pharmacovigilance •  SiGiR: Simplify and improve Global ICSR Repor-ng (one of EFPIA-‐IPVG strategic ini-a-ve) •  WHO-‐IPDM: WHO Interna-onal Program for Drug Monitoring •  WHO-‐UMC: Uppsala Monitoring Centre (WHO collabora-ng centre

Abbrevia-ons used in this presenta-on


IPV Regional Work-‐Stream

IPVG Ini5a5ve IFPMA-‐affiliated Country pharma

associa-ons

People from

specific pharma

companies

NRA


•  Selected Pharma companies or the Associa-on of mul-na-onal pharma companies (RDPAC) are regularly appointed by the Chinese FDA (renamed MNDA) and Provincial FDAs to contribute to the organisa-on of conferences and training events and for providing lecturers.

•  The Chinese FDA appoints for periods of 3 years as regular lecturers, selected Experts from pharma companies

•  RDPAC company Experts are currently involved into to the defini-on of the future E2B(R3) specifica-ons applicable to China

•  The RDPAC is involved in the review of draas of the new elements of the Chinese safety-‐regulatory framework aimed at mee-ng ICH requirements.

CHINA | RDPAC companies appointed by CFDA for providing exper-se


In the ASEAN area, India, Taiwan, Korea, experts from pharma companies are regularly appointed for providing lectures during conferences or training events organised by NRAs or as a coopera-on between the NRA and/or Pharma Associa-ons and/or Academic ins-tu-ons.

Recent examples:

•  Annual APEC-‐CoE PV training organised by the Korea’s KIDS in (Seoul)

•  Duke-‐NUS CoRE Graduate Cer-ficate on Fundamentals in Pharmaceu-cal Regula-on (Singapore)

•  ISoP Training organised in coopera-on with NRAs (e.g. Thailand, Australia, Indonesia)

Other Asia-‐Pacific countries | Private sector involved in collabora-ve ac-vi-es with Na-onal Regulatory Authori-es (NRA)


•  Involvement of EFPIA-‐IPV India Work-‐Stream and Indian pharma associa-ons into the making or revision of the Indian PV legisla-on framework (e.g. PvGI)

•  Involvement of selected companies in tes-ng concepts to be implemented in the future PV regula-on of Malaysia.

•  Review by the EFPIA-‐IPV Work-‐Stream of draas of new regula-on from Asia-‐Pacific countries. Provision of a consensus feed-‐back

•  ISoP Special Interest Group on Risk Minimisa-on methods for Asian Countries involving NRA representa-ves, Academic experts and PV professionals from pharma companies

Other Asia-‐Pacific countries | Private sector involved in collabora-ve ac-vi-es with Na-onal Regulatory Authori-es (NRA)


•  Members of the Russian pharma associa-on (AIPM) are regularly appointed by the Roszdravnadzor i.e. the Centre of Exper-se of Medicines Safety (RZN) to contribute to their training events and conferences.

o  QPPV cer-fica-on trainings o  Conferences promo-ng good PV prac-ce and harmoniza-on

•  Interna-onal Pharmacovigilance conference, organised jointly by the Roszdravnadzor and the AIPM in Moscow on October 10th 2018.

Ø  This milestone event involved speakers from CIOMS, WHO-‐UMC, ISoP, Mul-na-onal pharma companies in addi-on to officials from RZN and Health Authori-es of Eurasian Economic Union (EAEU)

Involvement of Pharma associa-ons into Conference and Training events Russian Federa5on


•  PV representa-ves members of the AIPM (Russian pharma associa-on) were largely involved into the Working Group on Na-onal PV Legisla-on Update in charge of elabora-ng the current pharmacovigilance regula-on and Good Vigilance Prac-ce.

•  This was undertaken through: o  Par-cipa-ng into regular official mee-ngs at the Roszdravnadzor o  Providing consultancy input o  Draaing the norma-ve documenta-on.

Involvement of Pharma associa-ons into pharma legisla-on making Russian Federa5on


•  AIPM and pharma industry associa-ons from Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan were involved into the working groups in charge of elabora-ng the supra-‐na-onal GxP regula-ons applicable to the Eurasia Economic union including:

Involvement of Pharma associa-ons into pharma legisla-on making Eurasian Economic Union countries (EAEU)

o  Good Pharmacovigilance Prac-ce o  Good Clinical Prac-ce o  Eurasian Registra-on Rules o  Requirements to CCDS o  List of Terms used in Eurasian GxP Documents.

•  Pharma industry associa-ons contribute to training and conference organised by the Health Authori-es of those countries.


•  Some NRAs are s-ll reques-ng MAHs to submit ICSRs on CIOMS forms on PDFs

•  Those CIOMS forms are entered manually by NRA staff into the VigiFlow container of the country whereas those ICSRs are available in E2B format in the safety database of the MAH

Ø Sub-‐op5mal seLng that can be fixed if NRAs accept receiving ICSRs as XML-‐E2B files.

Non-E2B National PV database

MAH Database E2B

VigiBase

ICSR submitted on paper

ICSRs in E2B format available but missed by VigiBase®

Public-‐Private Partnering for implemen5ng e-‐submission


E2B VigiFlow National PV database

MAH Database E2B

VigiBase

ICSRs submitted via XML

ICSRs in E2B format available

•  In 2015, Bayer PV Asia-‐Pacific collaborated with the UMC to deploy ICSRs submission in the format of E2B-‐XML files in all Asia-‐Pacific countries equipped using VigiFlow as na-onal pharmacovigilance database

Ø To address a broader array of ICSR submission issues with a global scope, EFPIA Interna5onal PV has set the SiGiR ini5a5ve to Simplify and Improve Global ICSR Repor5ng.

Public-‐Private Partnering for implemen5ng e-‐submission


✱  Monitor the ICSR repor-ng environment interna-onally

✱  Enter into a dialogues with NRAs looking for solu-ons to upgrade their na-onal PV database to the ICH-‐E2B standard for transmission of ICSR data

✱  Analyse the issues faced by those NRAs for upgrading their systems to E2B in the context of upcoming obsolescence of E2B(R2) and proposed solu-ons.

✱  Advocate for most harmonised E2B(R3) solu-ons, especially those to address Na-ve language.

✱  Collaborate with the UMC and IT system vendors for op-mizing solu-ons

✱  Review Apps & online portals for direct ICSR collec-on and transmission from reporters to NRAs, providing an industry view on their use when needed.

Ø  The SiGiR ini-a-ve is aiming at collabora-ng with IFPMA-‐affiliated pharma associa-ons of the specific countries as well as interna-onal organisa-ons engaged in global harmonisa-on.

Simplify and Improve Global ICSR Repor5ng | Goals of the SiGiR ini-a-ve


✱  As a first step, the SiGiR ini-a-ve is focusing on taking advantage from the new language facili-es added to E2B(R3) for hos-ng contents in Na-ve languages.

✱  The purpose of this approach is to maintain the harmonisa-on of the E2B framework in a context where an increasing number of countries reques-ng to receive contents in Na-onal languages are aiming at moving to E2B.

Ø  The overarching goal of the SiGiR ini5a5ve is to facilitate the implementa5on of harmonised solu5ons which will op5mise the use of resources on both NRA and MAH sides.

Purposes and goals of the EFPIA’s SiGiR ini5a5ve


✱ Thank you for your aUen-on

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