Medical Writing Generics and biosimilars Regulatory Public Disclosure

Volume 28, Issue 2 - Generics and biosimilars

Regulatory Public Disclosure

Abstract

Keeping up with regulatory public disclosure (RPD) globally is a challenge for us all. This regular RPD section of Medical Writing and EMWA’s RPD Special Interest Group (SIG) help you stay ahead of the game through information sharing.

References

  1. EMA’s invaluable reference to describe their end-to-end process for the journey of a centrally-authorised EMA medicine from lab to patient Available from: https://core-reference.us13.listmanage. com/track/click?u=c2b68d727a3b 5cd76327cee23&id=d989b6ae35&e=7985 8c7e19.
  2. On page 14, there is a great summary titled: “What information is publicly available during the evaluation of a new medicine and once a decision has been made?” complete with relevant web links.
  3. Read EMA’s EudraCT and EU Clinical Trial Regulation (CTR) Q & A document Available from: https://eudract.ema.europa.eu/docs/ guidance/EudraCT%20FAQ_for%20 publication.pdf
  4. The 32-page long 84 Q & A covers general, protocol, and results information, the EU CTR, and paediatric clinical trial information (protocol and results).
  5. PhUSE White Paper (March 14, 2019) titled “Retrospective versus proactive anonymization of narratives”: Available from: https://www.phusewiki.org/docs/ Deliverables/Narratives%20White%20 Paper%20Version%202.pdf
  6. This 17-page PhUSE White Paper by Rashmi Dodia and Gregory Campbell focuses on two approaches to produce anonymised narratives – retrospective and proactive. The retrospective section addresses challenges faced with qualitative methods (e.g., redaction) and the impact on data utility. Desirable features of a tool or software solution for redaction are included on page 10. In the proactive section, the needs for modern solutions and skills enhancement in order to meet Policy 0070 requirements are discussed. Suggestions on how to operationalise proactive anonymisation are also offered on page 15.
  7. All PhUSE white papers are available at: Available from: https://www.phuse.eu/white-papers
  8. EMWA RPD SIG members’ page: Available from: https://www.emwa.org/members/specialinterest- groups/regulatory-publicdisclosure- sig/
  9. Subpage for disclosure-related regulatory news updates: Available from: https://www.emwa.org/ members/special-interestgroups/ regulatory-public-disclosuresig/ regulatory-news-emwa-newsblast/.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk