Regulators Forum Agenda

WSMI Regulators Forum – 19 October 2017

Open session (regulators and WSMI delegates) – Thursday 19 October

1400 – 1425 – Opening – setting the scene

  • Brian McNamara, CEO of GSK Consumer Healthcare, Chairman, World Self-Medication Industry (WSMI) Board of Directors
  • John Skerritt, Deputy Secretary, Australian Department of Health


1425 – 1545 – Innovation in medicines reclassification (“switch”) 
What works best – product or substance based reclassifications? Is data protection/ exclusivity for newly reclassified OTC medicines appropriate?

  • UK incentives with regards to switching – Dr Jan MacDonald, Medicines and healthcare Regulatory Agency, UK – 20 min
    • The search for switch candidates – the Irish experience – Ms Lorraine Nolan, CEO, HPRA, Ireland – 20 min
    • Adoption of a proactive approach towards reclassification of medicines in the Singaporean context – Mr Mark Wong, Health Sciences Authority, Singapore – 20 min

Discussion

1545 – 1600 – Afternoon tea

1600 – 1720 – Regulatory reform initiatives for OTC medicines 

  • The Canadian experience – reforms to the regulation of self-care products, Mr Matthew Bown, National and Non-prescription Health Products Directorate, Health Products and Food Branch, Health Canada – 20 min
  • South Africa’s experience on the regulatory framework of OTC medicines – Dr Neil Gower, Chairperson Complementary Medicines Committee, South Africa – 20 min
  • Encouraging consumer health literacy about OTC medicine use, Dr Javier Humberto Guzman Cruz, INVIMA Colombia – 20 min

Discussion

 

List of Confirmed Participants – Regulators Forum 2017

No

Country/ Regulator

Confirmed participant(s)

Participant Position

1

Argentina/ ANMAT

Sebastien Duarte

Director of Institutional Relations and Advertising Regulation

2

South Africa/ MCC

Neil Gower

Chairperson, Complementary Medicines Committee

3

Germany/ BfArM

Martin Huber

Head of unit ‘Pharmacovigilance Risk Assessment Committee (PRAC) and other Committees’

4

Switzerland/ Swissmedic

Claus Bolte

Head of Clinical Review

5

USA/ USFDA

Theresa Michele

Director, Division of Nonprescription Drug Products

6

Taiwan/ TFDA

Shirley Pan

Section Chief, Division of Medicinal Products

7

UK/ MHRA

Jan MacDonald

Group Manager

Access & Information for Medicines & Standards, Vigilance and Risk Management of Medicines Division (VRMM)

8

Japan/ PMDA

Kazushige Murayama

Deputy Review Director, Office of OTC/Quasi-Drugs, PMDA

9

Singapore/ HSA

Mark Wong

Senior Regulatory Specialist from HSA’s Therapeutic Products Branch

10

Poland/ URPL

Grzegorz Cessak, Magdalena Pajewska-Lewandowska and one other representative

President of the Registration Office and Head of International Cooperation Unit, respectively

11

New Zealand/ Medsafe/MoH

Chris James

Group manager, Medsafe, Ministry of Health

12

UK/ EMA

Zaide Frias

Head of Division, Human Medicines Evaluation

13

Colombia/ INVIMA

Javier Guzman

General Director, INVIMA

14

Malaysia/ NPRA

Suhailah Abu Bakar

Principal Assistant Director, NPRA’s Centre for Product Registration

15

Canada/Health Canada

Matthew Bown

Senior Policy Analyst, Natural and Non-Prescription Health Products Directorate, Health Products and Food Branch 

16

Ireland/HPRA

Lorraine Nolan

Chief Executive, Health Products Regulation Agency

17

Thailand/ThaiFDA

Suchart Chongprasert

Director, Post-marketing Control Division,

Bureau of Drug Control

18

Romania/ANMDM

Nicolae Fotin

President

19

Australia/TGA

John Skerritt

Deputy Secretary, Health Products Regulation Group, Department of Health

20

Australia/TGA

Mark McDonald

Assistant Secretary, Complementary & OTC Medicines Branch, Health Products Regulation Group, Department of Health

21

Australia/TGA

Avi Rebera

Assistant Secretary, Regulatory Engagement and Planning Branch, Health Products Regulation Group, Department of Health

22

Australia/TGA

Mayada Kayali

Director, OTC Medicines Evaluation Section, Health Products Regulation Group, Department of Health

23

Australia/TGA

Unconfirmed

Director, International Regulatory Collaboration Section, Health Products Regulation Group, Department of Health