ë¸ë¡ì(PDF)

Book and pay 

before 12 JULY 2012 

and save up to 

SGD 3,696! 

• Main Conference: 18 & 19 September 2012 

• Workshops: 17 & 20 September 2012 

• Venue: Amara Hotel, Singapore 

Empowering you with pharmacovigilance regulatory updates, risk management 

best practices, audit and inspection tools for safer drugs in Asia 

UPDATES FROM 6 REGULATORY BODIES 

Dr. Wenmin Du 

Executive Director 

Shanghai Centre for Adverse 

Drug Reaction Monitoring, 

SFDA 

Dr Y K Gupta 

Head 

National Pharmacovigilance 

Programme, India 

Angela On 

Chief Executive Director 

Taiwan Drug Relief 

Foundation 

Dr. Nguyen Hoang Anh 

Responsible for Drug 

Information, Vietnam National 

Centre for Drug Information 

and ADR Reporting 

Mohamad Khalid Haji Zolkipli 

National Adverse Drug 

Reaction Monitoring Centre, 

Department of Pharmaceutical 

Services, Ministry of Health 

Brunei Darussalam 

Yagya Prasad Neupane 

Chairman 

Nepal Pharmacy Council 

Expert Panel Speakers Include: 

Prof Paul Lalvani 

Dean & Director 

Empower School of Health 

Consultant 

Uppsala Monitoring Centre 

Jean-Christophe Delumeau 

Head of Pharmacovigilance, 

Asia Pacific, 

Bayer Healthcare Global 

R&D Centre 

Rachel Wong 

Global Safety and Vigilance 

Manager, Asia Pacific, 

Bausch & Lomb 

Pai Raghavendra 

Regional Pharmacovigilance 

Manager, Asia Pacific, 

Lundbeck 

Dr Joy Li 

Director 

Pharmacovigilance & Medical 

Information, China R&D 

Bristol-Myers Squibb (China) 

Investment Co., Ltd. 

Michal Borawski 

International 

Pharmacovigilance Officer, 

Asia-Pacific Region 

Sanofi-Pasteur 

Dr. Ming Ji 

Senior Medical Director in 

Clinical Safety Evaluation 

Global Pharmacovigilance, 

Abbott 

Dr Vivek Ahuja 

Director, Pharmacovigilance 

Baxter Healthcare 

Asia Pacific 

Shinichi Nishiuma 

Vice President, 

Japanese Association 

of Pharmaceutical 

Medicine, Senior 

Medical Advisor, Senior 

Manager, Surveillance 

and Epidemiology, Global 

Patient Safety, 

Eli Lilly Japan 

Dr. Deepa Arora 

Global Head, Drug Safety & 

Risk Management, Lupin 

Dr. Badri Narayan Patnaik 

Head, Clinical Development 

and Pharmacovigilance 

Indian Immunologicals 

Don’t miss these expert-led workshops! 

Supported by: 

WORKSHOP 1: 

Practical steps in preparing for audit 

and inspection 

WORKSHOP 2: 

Achieving compliance with various 

country regulations in Asia while 

meeting company global safety 

requirements 

WORKSHOP 3: 

Developing Risk Management Plans 

(RMP) for Improved Post-Marketing 

Drug Safety Surveillance 

WORKSHOP 4: 

Establishing an Effective Early Detection 

System to Identify Safety Issues Early 

for Quick Rectifications 

Page 8 for more details. 

Researched and 

Developed by: 

PHONE: (65) 6722 9388 • FAX: (65) 6720 3804 • EMAIL: enquiry@iqpc.com.sg • WEB: www.pharmacovigilanceasia.com

Dear Colleague, 

Asia presents the greatest growth opportunities in 

pharmaceutical industry. Increasing drug consumption, R&D 

activities and awareness of drug safety issues have led to a 

rise in drug safety and pharmacovigilance alerts in Asia. 

Asia has seen major product recalls in recent years, such 

as the recall of Augmentin in China in 2011. This has led 

to regulatory authorities across Asia to tighten regulations 

to safeguard the consumer health, and implement more 

comprehensive processes to ensure due diligence. 

These new requirements place significant pressure on 

pharmacovigilance professionals. In addition, the 

diverse and often ambiguous regulatory requirements across 

the region, and the relative infancy of pharmacovigilance of 

the region add to the challenge faced. Regulatory authorities 

and pharmacovigilance professionals need to stay up-to-date 

with regulatory updates, key PV strategies and processes to 

ensure drug safety. 

3rd Annual Pharmacovigilance Asia has established itself 

as the perfect platform connecting regulators and 

pharmacovigilance professionals. This event promises to 

gather Heads of Pharmacovigilance, Directors of Drug Safety, 

Medical Affairs Officers, Medical Safety Managers from 

regulatory authorities and leading pharmaceutical companies 

to brainstorm and share insights on: 

• Developing and implementing risk management and 

minimisation plans for improved drug safety 

• Preparing for audit and inspection: 

practical steps to get it right 

• Achieving compliance in various country regulations in Asia 

while meeting global safety requirements 

• Meeting the challenges of AE reporting for post-marketing 

surveillance studies 

• Establishing an early detection system for improved 

drug safety 

• Best practices in benefit-risk analysis to capture and 

characterise drug profiles 

Reserve your seat at the conference and the four workshops 

today. Equip yourself with knowledge and skills in 

pharmacovigilance strategic planning and daily operations. 

See you in Singapore this September! 

Yours sincerely, 

Yuyuan Chen 

Conference Producer 

Pharma IQ – A Division of IQPC Worldwide 

What makes this the 

must-attend event for the 

pharmaceutical industry 

• The ONLY event that focuses entirely on the 

pharmacovigilance landscape in Asia: your best 

opportunity to meet the region’s leading experts 

on PV to learn best industry practices on how they 

overcome their PV challenges 

• 1 full day dedicated for regulatory updates by 

Uppsala Monitoring Centre, European Commission, 

and regulatory authorities of China, India, Taiwan, 

South Korea, Vietnam and Brunei 

• 10 industry best practice case studies to empower 

you with proven successful tools: hear what your 

peers are doing to comply with regulatory 

requirements, improve risk management and prepare 

for audit and inspections 

• 4 workshops to maximise your opportunity out 

of office: learn insights on (1) preparing audits 

and inspection, (2) implementing risk management 

and minimization plans, (3) establishing effective 

early detection system and (4) achieving compliance 

with various country regulations in Asia 

• 1 regulator-led roundtable discussion: sit along with 

regulators and discuss the future of 

pharmacovigilance in various countries and how you 

can play a part in shaping this 

• Over 6 hours of networking opportunities plus a 

dedicated speed networking session for you to 

interact with regulators and senior pharmacovigilance 

professionals 

“The IQPC Pharmacovigilance 

conference in Singapore, which is 

becoming an annual event is, to my 

knowledge, the most comprehensive 

information exchange and discussion 

forum dedicated to pharmacovigilance 

held in Asia so far.” 

Head of Pharmacovigilance Asia-Pacific, 

Bayer Healthcare Global R&D Centre 

P.S. Take advantage of our early bird offer! Save up to 

SGD2,700 when you book and pay before 12 July 2012! 

Flip to the back page and register now! 


CONFERENCE DAY 1 

Tuesday, 18 September 2012 

08:30 Registration and Refreshments 

09:00 Opening Address and Welcome from the Chairman 

09:10 An Update from Uppsala Monitoring Centre (UMC): 

The Global WHO Pharmacovigilance Network 

As WHO’s collaborating centre for international 

drug monitoring, UMC is important in promoting 

pharmacovigilance. Its role includes screening and 

analysing international adverse reaction data, 

communicating up-to-date scientific information, 

and setting up and running national 

pharmacovigilance programmes. In this event, UMC 

will address: 

• In-depth understanding of WHO International 

Drug Monitoring Programme 

• Building a harmonised global pharmacovigilance 

network: benefits and challenges 

• Understanding the advantages of a single global 

database system for safety information and 

analysis 

• Highlighting efforts to be made in Asia to 

establish a harmonised PV network 

A senior representative from Uppsala Monitoring 

Centre will address this topic. Please refer to 

www.pharmacovigilanceasia.com for updates. 

09:45 Updates on Safety Database Development at 

National ADR Centre in China: Key Benefits and 

Implications for ADR Reporting 

Order #81 of MOH, China - “Provisions for Adverse 

Drug Reaction Reporting and Monitoring” - was 

announced on May 4, 2011 and was effective since 

July 1, 2011. This new PV regulation places 

obligations on the SFDA and regional monitoring 

centres. In this topic, Dr. Wu will address: 

• What the new PV regulation is all about 

• Insight into China’s central and local level ADR 

reporting systems 

• Examining the challenges in setting up safety 

database and how these were overcome 

• Case study: how National ADR Centre 

developed and implemented technology support 

systems 

• Understanding the implications for ADR reporting 

Dr. Du Wenmin 

Executive Director 

Shanghai Centre for ADR Monitoring, SFDA 

10:20 Speed Networking – Maximise your networking 

time efficiently! Meet regulators and 

pharmacovigilance officers in this session and get 

settled into comfortable and open discussions 

throughout the conference. 

10:40 Morning Refreshments and Networking Break 

11:00 Regulatory Updates for Pharmacovigilance 

in South Korea – Ensuring you comply with market 

requirements 

Under Pharmceutical Affairs Law amendment 

on June 7, 2011, Korean Drug Safety Management 

Centre and Committee of Review of Safety 

Information were founded. In addition, PV planning 

(REMS) was piloted since July 2011. This 

presentation will address: 

• Understanding the Pharmaceutical Affairs Act 

amendments in 2011: What it entails and the 

implications for pharmaceutical companies 

• Pharmacovigilance planning (REMS) draft 

guidance and enforcement step by step until 

mandatory in 2017: how you prepare for it 

• Complying with Korea’s clinical trials and postmarketing 

reporting requirements 

A senior representative from Korea FDA will 

address this topic. Please refer to 


11:35 Surmounting the Challenges in Developing an 

Effective Pharmacovigilance Programme in India 

In December 2011, the Indian Council of Medical 

Research (ICMR) announced to lay down new 

guidelines to compensate volunteers for injuries 

during clinical research programmes. Meanwhile, 

under PV Programme of India (PvPI), additional 60 

ADR monitoring centres would be enrolled. This 

presentation will address: 

• The new ICMR guidelines’ impact on 

pharmaceutical industry – how to adjust 

to the new guidelines 

• Examining the major achievements of PvPI in the 

past year 

• Understanding the obstacles encountered when 

rolling out the PvPI programme and how these 

were overcome 

• Progress report – planning for next year’s 

activities: what you can look forward to 

• Lessons learned: how to build a nation-wide 

pharmacovigilance programme engaging all 

stakeholders 

Dr. Y K Gupta 

Coordinator, National Pharmacovigilance 

Programme, India, Professor and Head, 

Department of Pharmacology, 

All India Institute of Medical Sciences 

12:10 Lunch and Networking Break 

13:10 Updates from the European Commission: 

Implementing a New Pharmacovigilance System in 

Europe 

On 15 December 2010, the European Union 

enacted a new set of pharmacovigilance 

legislations that will take effect in July 2012. Under 

the new legislations, new PV system will be 

established to address new requirements on 

marketing authorisation holders, national 

competent authorities and the EMA, amongst 

others. This topic will address: 

• What is the new PV system all about 

• Strengthening and rationalising the existing 

safety monitoring system: what to be done 



Tuesday, 18 September 2012 

• How to implement measures for better 

prevention, detection and assessment of adverse 

reactions of medicine to improve patient safety 

and public health 

• Enabling patient direct reporting to the 

regulatory authorities: experiences and 

suggesitons 

• Broadening ADR reporting coverage to ensure 

better drug safety 

A senior representative from European 

Commission will address this topic. Please refer to 


13:45 Pharmacovigilance Updates in Taiwan – Key 

implications for pharmaceutical companies 

Draft “Guidelines on RMP and Suggested Format 

and Content” was announced by Taiwan FDA in 

Jan 2011. In addition, Taiwan FDA announced 

in September 2011 that they would start PV 

inspections. Considering these changes, the 

speaker will address: 

• Assessing the latest development in RMP 

Guidelines, the applied scope and implications 

for pharmaceutical companies 

• Understanding the inspection requirements 

• New regulations on clinical trial reporting and 

the impact on pharmaceutical companies: 

how you prepare for the change 

• Complying with Taiwan’s reporting guidelines 

Angela On 

Chief Executive Director 

Taiwan Drug Relief Foundation 

14:20 Regulatory updates for Pharmacovigilance in 

Vietnam – Effectively operate in the Vietnamese 

market 

Vietnam MOH took a major step in 

pharmacovigilance when National Drug 

Information and Adverse Drug Reaction (DI&ADR) 

Center was estabished in 2009. 

PV framework was established with active 

surveillance as key element. This presentation will 

include: 

• Developing regulations for ADR reporting in 

Vietnam: The objectives and guidelines 

• Updates on post-marketing surveillance study 

requirements 

• Examining the current reporting guidelines and 

their implications for the pharmaceutical industry 

Dr. Nguyen Hoang Anh 

Responsible for Drug Information 

Vietnam National Centre for Drug Information and 

ADR Reporting 

14:55 Afternoon Tea and Networking Break 

15:25 New guidelines on ADR reporting in Brunei – 

How will it impact you 

• Introducing the new guidelines and important 

updates on ADR reporting requirements in Brunei 

• Contributions of the guidelines to the ASEAN 

harmonization programme 

• Brunei’s experience in having industry comply 

with the new ADR reporting: how successful is it 

• Exploring strategies to further improve ADR 

reporting to ensure drug safety 

Mohamad Khalid Haji Zolkipli 

National Adverse Drug Reaction Monitoring Centre, 

Department of Pharmaceutical Services 

Ministry of Health Brunei Darussalam 

16:00 Status of Pharmacovigilance in Nepal 

• Insightful understanding of current 

pharmacovigilance situation in Nepal 

• Late update on national drug policy 

• Evaluating the market study in delivering safe 

medicine by local manufacturers 

• Examining the role of Nepal Pharmacy Council 

in controlling the quality of pharmacy manpower 

who are licentiated with the council. 

• Pharmacovigillance network in Nepal and scope 

Yagya Prasad Neupane 

Chairman 

Nepal Pharmacy Council 

16:35 Regulator-led Roundtable Discussion 

In this session, participants can choose to participate 

in one of the regulator-led groups focused on 

pharmacovigilance best practices and updates in 5 

different regions, namely: Greater China, Southeast 

Asia, India, Northeast Asia and EU & US. You will have 

the chance to go up-close and personal with 

regulators and experts in the specific region to 

discuss PV issues and have your queries clarified. 

Prepare your questions before the session to have a 

fruitful discussion. 

Key discussion points include: 

• Are there PV reporting guidelines and fields to be 

clarified 

• Where are the FDA agencies heading to 

• What are the likely revision areas and how do 

they impact the pharmaceutical industry 

• How pharmaceutical industry can play its role 

to help establish ADR database and in postmarketing 

surveillance programme 

17:10 Chairman’s Closing Remarks 

17:15 Close of Conference Day One 

“Had an overall understanding of pharmacovigilance 

running in Asia, particularly in ASEAN. It is helpful 

for me to make a plan locally and accelerate 

pharmacovigilance strategy locally.” 

Director of Regulatory Affairs, Nycomed China 



Wednesday, 19 September 2012 

08:30 Registration and Refreshments 

08:50 Opening Address and Welcome from the Chairman 

09:00 Pharmacovigilance Challenges in Developing Asian 

Countries: the Landscape and Potential Solutions 

• Overview of the pharmacovigilance state in 

developing Asian countries 

• Pinpointing the challenges faced in developing 

Asian countries: what they are and what 

implications they have for drug safety and 

pharmaceutical companies 

• Evaluating solutions to overcome these 

challenges 

• Case studies: what can we learn from successful 

experiences in Asia 

Prof Paul Lalvani 

Dean & Director, Empower School of Health 

Consultant, Uppsala Monitoring Centre 

09:35 Case Study: Preparing for Audit and Inspection: 

Practical Steps to Get it Right 

• Reviewing how pharmacovigilance audit and 

inspection practices evolved globally and unique 

challenges in Asia 

• Planning targeted and routine inspections at 

regional level 

• Exploring practical steps to train local 

pharmacovigilance staff to meet country-specific 

inspection and audit requirements as well as 

global standards 

Pai Raghavendra 

Regional Pharmacovigilance 

Manager, Asia Pacific 

Lundbeck 

10:10 Morning Refreshment and Networking Break 

10:40 Pharmacovigilance Challenges in Newer Vaccines: 

Present and the Evolving Future 

• Reviewing global vaccinovigilance methodologies 

• Understanding the road blocks in vaccine related 

causality assessment. 

• Assessing next generation vaccines and safety 

monitoring challenges. 

• Case Studies 

• Evaluating the importance of data mining for 

signal generation. 

Dr. Badri Narayan Patnaik 

Head, Clinical Development and 

Pharmacovigilance Indian Immunologicals 

11:15 Impact of the new EU Pharmacovigilance 

Standards on the Safety Regulatory Environment 

in Asia 

• Understand in detail the new EU 

pharmacovigilance standards 

• Examine the impact on drug safety regulatory 

environment in Asia: will Asia follow suit soon 

• Evaluate how regulatory authority may shape 

guidelines to maintain country specific 

requirements 

• How pharmaceutical companies should prepare 

for the change 

Jean-Christophe Delumeau 

Head of Pharmacovigilance, Asia Pacific 

Bayer Healthcare Global R&D Centre 

11:50 Case Study: Best Practices and Future Challenges 

in Japan on Post-Marketing Surveillance – 

Observational Study and EPPV Programme 

• Examining the post-marketing surveillance 

systems in Japan 

• Case study: The Early Phase Post-Marketing 

Vigilance (EPPV) programme in Japan 

• How to evaluate the unique regulatory 

requirements in your country The backdrop for 

signal detection and risk management 

• Exploring approaches to shape EPPV to comply 

with local regulatory requirements 

Shinichi Nishiuma 

Vice President, Japanese Association of 

Pharmaceutical Medicine, Senior Medical 

Advisor, Senior Manager, Surveillance and 

Epidemiology, Global Patient Safety, 

Eli Lilly Japan 

12:25 Lunch and Networking Break 

13:25 Case Study: Best Practices in Benefit Risk 

Analysis to Capture and Characterise a Drug 

Profile 

• Understanding the regulatory reporting 

requirements for marketed biopharmaceutical 

products 

• Implementing Multi-Criteria Decision Analysis 

(MCDA) for quantitative modelling of a drug’s 

benefit-risk profile: how to do this 

• Evaluating the challenges in characterising a 

drug’s benefit-risk profile 

• Exploring best practices in benefit risk analysis 

to capture and characterise a drug profile 

Deepa Arora 

Global Head, Drug Safety & Risk 

Management 

Lupin 

14:00 Case Study: Achieving Compliance with Various 

Country Regulations in Asia While Meeting Global 

Safety Requirements 

• Reviewing the challenges of complying with 

changing country regulations in Asia 

• Examining approaches in setting up a Local Drug 

Safety Office (LDSO), Asia 



Wednesday, 19 September 2012 

• Incorporating various regulatory requirements 

into SOPs: what were the challenges 

• Ensuring the pharmacovigilance practices are 

compliant with global safety requirement: how to 

do this successfully 

Michal Borawski 

International Pharmacovigilance Officer, 

Asia-Pacific Region 

Sanofi-Pasteur 

14:35 Developing and Implementing Pro-Active 

Pharmacovigilance (PV) Strategies to Ensure Drug 

Safety 

• Understanding in-depth the essential 

components of pharmcovigilance (PV) 

• Developing and implementing pro-active PV 

strategies to ensure drug safety: how to manage 

PV system, safety planning and risk management 

and mitigation at a high level 

• Turning the strategies into detailed practical 

steps 

• Exploring how to capitalise on the pro-active PV 

strategies for better drug safety 

Dr. Ming Ji 

Senior Medical Director in Clinical Safety 

Evaluation Global Pharmacovigilance 

Abbott 

15:10 Afternoon Tea and Refreshement Break 

15:40 Case Study: The Impact of Ex-Asia 

Pharmacovigilance Regulations in Bausch + Lomb 

Asia-Pacific 

• An overview of the new European Commission 

Pharmacovigilance Legislation and other 

regulations – the impact on the safety monitoring 

of globally registered products within Asia-Pacific 

• Understanding communication requirements for 

active substances’ worldwide exposure 

• Exploring other impacts of Ex-Asia 

Pharmacovigilance Regulations on the safety 

monitoring systems in Asia-Pacific 

• Assessing the strategies to meet ex-Asia 

Pharmacovigilance Regulations in Asia-Pacific 

Rachel Wong 

Global Safety and Vigilance Manager, 

Asia Pacific 

Bausch & Lomb 

16:15 Case Study: Protecting Pharmaceutical 

Companies in China from Legal Challenges 

Pertaining to Drug Safety 

• Understanding Chinese regulatory requirements: 

your rights and obligations 

• Update on current practices of processing legal 

suits and compensation claims in China 

• Case study: sharings on how you prepare and 

protect your companies from legal challenges 

pertaining to drug safety 

Dr Joy Li 

Director 

Pharmacovigilance & Medical Information, 

China R&D 

Bristol-Myers Squibb (China) Investment 

Co., Ltd. 

16:50 Chairman’s Closing Remarks 

16:55 Close of Conference Day Two 

“This conference offers the opportunity 

for those working in pharmacovigilance 

to share expertise and learn about best 

practices and challenge the way they 

do things.” 

Pharmacovigilance Manager, MSD 


WORKSHOPS 

Monday, 17 September, 2012 

WORKSHOP A 

0900 – 1200: Monday, 17 September 2012 

(inclusive of 30-min refreshment and networking break) 

Practical steps in preparing 

for PV inspection 

To ensure regulatory compliance, inspections are conducted 

regularly which require much and careful preparation work. 

Different stakeholders will be involved as well which adds 

to the complexity. It is critical for the team to be properly 

prepared and make sure every step is right to lead to a 

fruitful inspection. 

Dr. Ming Ji will share through his vast experience in this 

field the common challenges, and give insights on practical 

steps to prepare for PV inspection. 

WORKSHOP AGENDA 

0830 Registration 

0900 Welcome from Workshop Leader 

0905 Understanding PV inspections 

• purposes 

• inspection documents 

• key requirements 

• reporting timeline 

0930 What to prepare 

• before 

• through and 

• after an inspection 

1000 Preparing documents 

• what are they 

• which sections require special attention 

• acquiring information from departments 

1030 Refreshment and Networking Break 

1100 Developing good communications strategies 

• why communications are important 

• common challenges and impact on inspection 

results 

• what works best 

1130 Conducting a mock inspection 

1200 End of workshop 

About your workshop leader: 

Dr. Ming Ji, MD, MS. 

Senior Medical Director, Global Pharmacovigilance 

Abbott 

Dr. Ming Ji had extensive experience in clinical drug 

safety, pharmacovigilance and clinical pharmacology. 

Prior to his current post, Dr. Ji served as medical director 

at Pharmacovigilance Department of TAP Pharmaceutical 

Inc., executive director at Global Safety of Amgen Inc., and 

medical monitor in Clinical Development of Wyeth. 

WORKSHOP B 

1400 – 1700: Monday, 17 September 2012 


Achieving compliance with various 

country regulations in Asia while 

meeting company global safety 

requirements 

As Asia presents the largest growth opportunity for 

pharmaceutical industry, many are taking foothold in 

Asia to gain market share. One major challenge faced is 

to ensure compliance with various country regulations, 

which are rapidly changing and evolving. In addition, the 

company’s global safety requirements add to the burden of 

pharmacovigilance professionals. 

In this workshop, you will learn how to effectively comply 

with various country regulations in Asia while meeting 

company’s global safety requirements. 




1405 Understanding PV regulations in Asia 

• What are PV regulatory requirements in Asian 

countries 

• How PV regulations differ in various countries 

• Implications for PV managers 

1430 Achieving compliance in Asia 

• what areas to look out for 

• ensuring due diligence 

• conducting mock inspections internally 

1500 Making compliance simple 

• SOPs to incorporate regulatory requirements 

• company global safety requirements 


1600 Case study of Sanofi-Pasteur 

• what it does to comply with Asian regulations and 

company global safety requirements 

• common challenges and impact on PV compliance 

• strategies to overcome the challenges 

1630 Hands-on application 

• how your PV practices can be improved 

• will Sanofi-Pasteur’s way work for you 

• Modifying your PV practices to make compliance 

reliable and simple 


This workshop will be led by an industry expert. Look out for 

our workshop leader announcement at 

www.pharmacovigilanceasia.com. 


WORKSHOPS 

Thursday, 20 September, 2012 

WORKSHOP C 

0900 – 1200: Thursday, 20 September 2012 


Developing Risk Management Plans 

(RMP) for Improved Post-Marketing 

Drug Safety Surveillance 

Risk management planning (RMP) has been developped in 

EU and US for improved post-marketing drug surveillance. 

In EU, it is mandatory for companies to submit a RMP at the 

time of application for a Marketing Authorization for most 

products. 

With fast evolving regulations in Asia to address drug safety, 

RMP will soon be adopted and implemented. In fact, Korea 

annouced draft REMS (similar to RMP) in August 2011, to 

be mandatory in 201 7, and Taiwan announced RMP draft in 

2011 and started PV inspections in September 2011. 

This workshop will equip you with knowledge on specific 

elements of a RMP, the detailed template and guidelines, 

and how you can develop RMP to improve your postmarketing 

drug safety surveillance. 




0905 Understanding RMP 

• purposes 

• when to submit a RMP 

• what are the key elements 

0930 Element 1: safety specification 

• defining identified and potential risks 

• limitations of clinical research program 

• missing information of drug safety 

1000 Element 2: pharmacovigilance plan 

• what is the scope 

• what plan details are required 

• resolving the uncertainties in drug safety 


1100 Element 3: risk minimization plan 

• the plan’s scope and purposes 

• measures to reduce severity or frequency of 

known ADRs 

1130 Hands-on exercise to develop a RMP for your 

company 


This workshop will be led by an industry expert on RMP. 

Look out for our workshop leader announcement at 


WORKSHOP D 

1400 – 1700: Thursday, 20 September 2012 


Establishing an Effective Early 

Detection System to Identify Safety 

Issues Early for Quick Rectifications 

Rare but serious adverse events associated with drugs 

are often nearly impossible to detect in pre-licensure 

studies and require monitoring after introduction to market. 

Pharmaceutical companies thus look to buidling an 

effective early detection system to identify safety issues 

early for quick rectifications. 

This workshop will equip you with knowledge and strategies to: 

• aggregate and integrate drug safety data from 

various sources 

• uncover hidden insights in unstructured sources 

• mitigate potential post-marketing risks 

• drive better drug development decisions 




1405 Understanding early detection system 

• the purposes 

• significance of early detection system for 

drug safety 

• common methodologies and analytical methods 

1430 Data input 

• various sources of data 

• transform, cleanse and standardise data 

• aggregate and integrate drug safety data 

1500 Uncovering hidden insights 

• unstructured texts and their importance to drug 

safety 

• text mining and proactive scanning for safety 

signals 


1600 Improving drug development decisions 

• methodologies in early detection system 

• strengths and limitations of analytical methods 

• applying early detection system throughout a 

drug’s life cycle 

• case study 

1630 Hands-on application 

• limitations in your early detection system 

• how your early detection system can be 

improved 


This workshop will be led by an industry expert on 

establising early detection systems. Look out for our 

workshop leader announcement at 



Take advantage of the exclusive 

sponsorship opportunities this 

event offers 

As pharmceutical companies are rapidly building up expertise 

in pharmacovigilance in Asia, they are actively seeking 

solutions and consultancy offers in the areas of: 

• Risk management and mitigation 

• Auditing and inspection preparation 

• Pharmacovigilance consultancy 

• Data mining, signal detection, ADR reporting, 

drug safety analysis 

• Legal advice 

This truly regional event only brings together your principal 

clients, but also allows you to interact with them one-to-one. 

Take advantage of this opportunity to enjoy sponsor benefits: 

1. Achieve thought leadership by speaking and exhibiting in 

this event: showcase your expertise, superior products and 

services, and impress your prospects 

2. Maximise your exposure by leveraging on our 

marketing resources, including print advertisements, online 

advertisements, website, email campaigns to over 10,000 

pharmacovigilance personnel in Asia 

3. Optimise your influence: chair the event and shape the 

event flow – it is your opportunity to influence the 

audience and position your organisation as industry leader 

4. Position yourself a step forward from other vendors by 

hosting networking lunch – let it be your corporate lunch! 

Discuss business in an informal way 

5. Tailored business development arrangements: targeted 

prospect invitation and pre-arranged meetings to ensure 

you are meeting the right people and developing the 

business relationship you desire 

Sponsorship opportunities are deliberately limited. Contact us 

today to explore how we can best leverage this platform to 

customerise a package that achieves your business objectives: 

Call +65 6722 9388 or email sponsorship@iqpc.com.sg. 

“Good forum to discuss Asia Pacific 

regulations. Good networking opportunities 

to set up a pharmacovigilance working 

group in this region!” 

Balasubramanian Sankaranarayanan, 

Head of UFESCIENCES EU&APAC, Cognizant

ë¸ë¡ì (PDF)

Create successful ePaper yourself

Delete template?

Save as template?

ë¸ë¡ì(PDF)