Events – Accestra Consulting

CPHI Milan 2024: Accestra to Present Building a Successful DMF Application Strategy for Packaging Material Registration in China

Accestra Marketing Team — Tue, 24 Sep 2024 05:15:27 +0000

Time and Location:

8-10 October 2024

Fiera Milano

28, Strada Statale Sempione, 20017, Rho, Lombardia, Italy

INTRODUCTION

CPHI is where the global pharma community comes together to foster connections and ignite partnerships. We’re excited to announce that April Wang, Regulatory Affairs Manager at Accestra Consulting, will be presenting at this prestigious event. She will offer valuable insights on China DMF registration strategies for packaging materials, sharing her expertise with attendees.

Presentation: Building a Successful DMF Application Strategy for Packaging Material Registration in China

Time: Wednesday, 9 October 2024 12:05 PM to 12:30 PM (CET)

Location: Hall 20 – 20C33

key takeaways

China’s DMF Regulatory Framework & Reform
China DMF Registration Pathways & Strategies
Registration Procedures, Timeline & Costs
Dossier Requirements & Checklist
Technical Requirements: Key Considerations
Technical Requirements: Pitfalls & Tips

Speaker:

April Wang

Senior Regulatory Affairs Manager

Accestra Consulting

About me

April possesses an in-depth understanding of Chinese pharmaceutical regulations and has accumulated extensive hands-on experience with China DMF filings and regulatory consulting projects. Her expertise is backed by her strong communication network with key Chinese authorities, including the NMPA and CDE.

Throughout her career, Ms. Wang has successfully supported numerous international pharmaceutical companies, both large and small, in their efforts to enter the Chinese market.

Discover more about the presentation by clicking the link below:

https://visitor.cphieventplanner.com/event/cphimilan2024/planning/UGxhbm5pbmdfMjA0OTc2OQ==

CPHI North America 2024: Accestra to Present China Drug Master File (DMF) Comparing with U.S. and EU

Accestra Marketing Team — Mon, 29 Apr 2024 07:10:09 +0000

Time and Location:
07 – 09 May 2024 |Pennsylvania Convention Center, Philadelphia

INTRODUCTION

CPHI creates connections and inspires partnerships across the global pharma community. Access endless opportunity to grow your business and expand your network at the heart of Pharma!

We’re thrilled to announce that our Senior Regulatory Affairs Raymond Ng will take the stage to present Accestra Consulting. He will share valuable insights and expertise on the topics of China Drug Master File (DMF) Comparing with U.S. and EU.
Presentation:China Drug Master File (DMF) Comparing with U.S. and EU

May 7th 2024, 15:00-15:25 (EST)

Key Takeaway Points

China DMF regulatory framework & reform
China DMF registration pathways & requirements
Registration procedures, timeline & costs
Comparison of China DMF with U.S. & EU
Technical requirements: pitfalls & tips

Presenter:

Raymond Ng,Accestra Consulting Company Senior Regulatory Affairs Manager

raymond@accestra.com

Mr. Ng is based in China with almost a decade of regulatory affairs experience for Chinese market with a master’s degree from the University of Nottingham.
He has extensive knowledge of Chinese pharmaceutical regulatory requirements and has worked on numerous regulatory submissions with Health Authorities.
Mr. Ng has strong communication and practical experience dealing with the Chinese health authorities including NMPA (formerly CFDA) and CDE.
A successful track record of supporting top 50 pharma companies as well as biotech and medtech with market entry into China.

See you there!
– Accestra Events Team

RAPS Euro Convergence 2024: Accestra to Present Exploring Regulatory Pathways for Drug Registration in China: Strategic Approaches

Accestra Marketing Team — Mon, 29 Apr 2024 06:35:16 +0000

Time and Location:
6-8 May 2024 |Berlin Congress Center Alexanderstraße 11, 10178 Berlin, Germany

INTRODUCTION

RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy.

We’re thrilled to announce that our visionary CEO Helen Ye will take the stage to present Accestra Consulting. She will share valuable insights and expertise on the topics of Strategic Options of Regulatory Pathways for Drug Registration in China.

Presentation: Exploring Regulatory Pathways for Drug Registration in China:Strategic Approaches

7 May 2024, 15:05 – 16:05 (CET)

Key Takeaway Points

Standard drug registration procedures in China
Accelerated review pathways
Special pathways to access China
Registration strategy & tips

Presenter:

April Wang, Regulatory Affairs Manager at Accestra Consulting

april.wang@accestra.com

Ms. Wang is a senior regulatory affairs consultant specializing in the Chinese market with a Double Master’s Degree from Fudan University and Luiss Guido Carli University.
She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with DMF filing & regulatory consulting projects during daily work.
Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
A successful track record with supporting international pharma with market entry into China including big and small pharma

See you there!
– Accestra Events Team

DIA Global Forum for Qualified Persons for Pharmacovigilance (QPPV): Accestra to Present China RPPV/QPPV at DIA Global Forum 2023 in Amsterdam

Accestra — Tue, 24 Oct 2023 05:21:53 +0000

This Forum provides valuable insights into the most pressing issues QPPVs are facing today. This event has limited capacity, register early!

Time and Location:

8 – 9 November 2023 | Amsterdam, Netherlands

Meet us in Amsterdam, engage with our speakers face to face about China QPPV requirements and practices, and get real-time feedback for your questions.

INTRODUCTION

The DIA Global QPPV Forum is a must-attend conference for anyone involved in pharmacovigilance. With a focus squarely on the most critical issues in today’s industry, tackling global QPPV challenges, trends demanding heightened QPPV awareness, and the transformative impact of modern technology. Plus, it will continue the ever-popular ‘QPPV Talks,’ offering quick, inspirational insights drawn from real-world cases.

Expect valuable insights from regulatory authorities and international industry leaders, ensuring this conference addresses the pressing issues that QPPVs face today. Mark your calendar for the ‘Hot Topics’ session, a not-to-be-missed highlight!

Join us at the DIA Global QPPV Forum to network with your peers, gain valuable insights, and stay ahead in this constantly evolving role.

Proudly presented by Accestra, an in-field expert in the pharmaceutical and pharmacovigilance industry, we look forward to sharing our expertise on ‘China QPPV.’ Don’t miss this unparalleled opportunity to elevate your understanding and stay ahead of the curve.

9^th November 2023, 9:00 – 10:30 AM (CET time)

Location: Mercure Hotel Amsterdam City

Address: Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Demystifying China’s RPPV/QPPV Landscape

Regulatory Framework of China Pharmacovigilance
Overview of China RPPV/QPPV
China RPPV vs EU QPPV
Authority Inspection Key Points
Tips and Regulations Overview

SPEAKER

Marylene Zhan, Senior PV Manager at Accestra Consulting

Marylene.zhan@accestra.com

Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs. With a Master’s Degree from the Zhongnan University of Economics and Law. Marylene is a seasoned bilingual and bicultural consultant who specializes in China regulatory compliance and pharmacovigilance services (RA/PV). She has a wealth of knowledge on Chinese Pharmaceutical regulations and in-depth insight into dealing with Chinese market access requirements. Marylene has a rich experience in serving international pharma companies with market entry into China, providing support in the areas of adverse event monitoring and reporting, literature screening, PV agreements, Chinese GVP and local regulations, SOP & PSMF writing, and more.

RAPS Convergence 2023: Accestra to Present Strategic options of regulatory pathways for drug registration in China

Accestra Marketing Team — Fri, 08 Sep 2023 04:34:11 +0000

Time and Location:
3 – 5 October 2023 | Palais des Congrès de Montréal 1001 Pl. Jean-Paul-Riopelle Montreal, QC

INTRODUCTION

Presentation: Strategic options of regulatory pathways for drug registration in China

4 October 2023, 14:00 – 15:00 (EDT)

Key Takeaway Points

Overview of drug registration in China
Accelerated review pathways
Special pathways of entering China
Registration strategy & tips

Presenter:

Helen Ye, CEO at Accestra Consulting

helen.ye@accestra.com

Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China.
She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customized solutions to international pharmaceutical companies and government institutions.
She leads the registration team to plan, develop and implement compliance strategy for top pharma clients and with successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices, and others.
Ms. Ye has strong communication network with Chinese authorities (e.g., NMPA and CDE) and industry experts in China.

See you there!
– Accestra Events Team

BioProcess International: Accestra to Present Biologics Approval & Accelerated Pathways in China

Accestra Marketing Team — Fri, 08 Sep 2023 04:18:18 +0000

Time and Location:
19 – 21 September 2023 | Boston Convention and Exhibition Center

INTRODUCTION

The largest bioprocessing event for learning how to accelerate promising biologics, cell & gene therapies towards commercial success. Access the science, technologies, and contacts you need to improve efficiencies across all phases of biopharmaceutical development and production.

We’re thrilled to announce that our visionary CEO Helen Ye will take the stage to present Accestra Consulting. Discover how we’re paving the way for accelerated pathways in biologics registration in China.

Presentation: Biologics Approval & Accelerated Pathways in China

20 September 2023, 16:00 (EDT)

Key Takeaway Points

Overview of biologics registration in China
Accelerated review pathways
Special pathways of entering China
Registration strategy & tips
Case study

Presenter:

Helen Ye, CEO at Accestra Consulting

helen.ye@accestra.com

Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China.
She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customized solutions to international pharmaceutical companies and government institutions.
She leads the registration team to plan, develop and implement compliance strategy for top pharma clients and with successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices, and others.
Ms. Ye has strong communication network with Chinese authorities (e.g., NMPA and CDE) and industry experts in China.

See you there!
– Accestra Events Team

CPHI Barcelona: Accestra to Present China Biologics Accelerated Registration at BioProduction of CPHI 2023

Accestra — Tue, 25 Jul 2023 10:32:39 +0000

Time and Location:
24 – 26 October 2023 | Fira Barcelona Gran Via, Spain

INTRODUCTION

CPHI BioProduction is dedicated to leveraging partnership and collaborations to achieve greater success for production and market access of biologics. We are thrilled to be part of this exciting conference in the vibrant city of Barcelona on 24-26 October.

We are delighted to announce that our Senior Regulatory Affairs Manager April Wang will be sharing invaluable knowledge on how to expedite your biologics registration process in China. If you’re eager to discover practical strategies to accelerate the registration of your biologics in one of the world’s most dynamic markets, you do not miss this presentation session!

Join us at CPHI BioProduction in Barcelona, and together, let’s forge alliances, foster innovation, and pave the way for even greater success in the accessibility of biologics. We look forward to meeting you there!

2023 October 25, 11:45 – 12:15 PM (CET time)
Fira Barcelona Gran Via, Spain

Biologics Approval & Accelerated Pathways in China

Fast-track registration pathways in China
Special registration procedures in China
Imported drugs for urgent clinical use & real world clinical data
Case studies
Q&A

SPEAKER:

April Wang, Senior Regulatory Affairs Manager at Accestra Consulting
april.wang@accestra.com

Ms. Wang is a senior regulatory affairs consultant supporting pharmaceutical companies with understanding Chinese regulatory requirements.
She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with DMF filing & drug (both biologics and chemical drugs) registration projects during daily work.
Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
A successful track record with supporting international pharma with market entry into China including big and small pharma.

See you there!
– Accestra Events Team

CPHI Barcelona: Accestra to Present China Pharmacovigilance at BioProduction of CPHI Europe 2023 in Barcelona

Accestra — Fri, 21 Jul 2023 04:44:09 +0000

Time and Location:
24 – 26 October 2023 | Barcelona, Spain
Meet us in Barcelona, engage with our speakers face to face about China GVP and relevant regulation changes, and get real-time feedback for your questions.

INTRODUCTION

Pharmacovigilance regulations in China are constantly evolving and rapidly changing. With China becoming increasingly important for pharmaceutical companies, it is essential to remain updated on the latest regulatory developments to ensure compliance and safety.

As a leading global conference and exhibition on pharmacovigilance, Accestra is proud to sponsor and present about China GVP at the 9th Annual International Conference and Exhibition on Pharmacovigilance, Regulatory Affairs, Risk Management, and Clinical Trials.

2023 October 25, 16:00 – 16:30 PM (CET time), Fira Barcelona Gran Via, Spain

Navigating the Latest Regulations for Pharmacovigilance in China

Overview of China PV framework
Updates on China's GVP policies
China's GVP requirements
Best practices for compliance with China's GVP requirements and authority inspection key points
Tips and pitfalls
Q&A

SPEAKER:

Marylene Zhan, Senior PV Manager at Accestra Consulting
Marylene.zhan@accestra.com

See you there!
– Accestra Events Team

China Drug Registration Webinar

Zhao Lu — Wed, 26 Apr 2023 11:34:36 +0000

Accestra Webinars

In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 16th May 2023.

Drug registration overview in China

The webinar will cover these topics:

China Drug Regulatory Framework
China Drug Registration Overview
Imported Drug Registration including overseas data acceptance and regulatory challenge

Date :
16 May 2023, Tuesday

Time :
15:00 – 16:00 China
17:00 – 18:00 Sydney
05:00 – 06:00 EST
09:00 – 10:00 CET

SPEAKER:

Marylene Zhan
Senior RA Manager at Accestra Consulting

See you there!
– Accestra Events Team

Upcoming complimentary webinars in May & June 2023:

21-Jun-23 Post-marketing Pharmacovigilance in China

Meet with Us at RAPS 2023 Euro Convergence in Amsterdam

Zhao Lu — Wed, 26 Apr 2023 11:15:38 +0000

Conference Introduction

RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Euro. We are excited to attend the conference in Amsterdam on 10-12 May. This certainly is a valuable opportunity for regulatory affairs professionals worldwide to connect, learn from one another, discuss industry trends & best practices, and expand networks!

If you are interested in Chinese market or would like to learn more about it, our Business Development Manager April Wang would be happy to schedule a meeting or chat with you during coffee/tea breaks. We look forward to seeing as many of you as possible in Amsterdam soon!

Date :
10-12 May 2023

Location:
Park Inn by Radisson Amsterdam City West, La Guardiaweg 59, 1043 DE, Amsterdam