Marketing Authorization Application (maa) - Pharma

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Relevant Publications

Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan.

Issue Release: 2024

Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective.

Issue Release: 2024

Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.

Issue Release: 2024

Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

Issue Release: 2023

A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration.

Issue Release: 2023

Innovative Genoceuticals in Human Gene Therapy Solutions: Challenges and Safe Clinical Trials of Orphan Gene Therapy Products.

Issue Release: 2023

A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China.

Issue Release: 2021

Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.

Issue Release: 2021

Hurdles in gene therapy regulatory approval: a retrospective analysis of European Marketing Authorization Applications.

Issue Release: 2018

[From the licensure of vaccines to the recommendation of the Standing Committee on Vaccination in Germany : criteria for the assessment of benefits and risks].

Issue Release: 2015

[Setting up a department of molecular pathology in oncology in a pathology laboratory (LPCE, CHU de Nice)].

Issue Release: 2013

Development and regulation of biosimilars: current status and future challenges.

Issue Release: 2013

Testosterone-topical fortigel - cellegy: fortigel, tostrex.

Issue Release: 2003

Nesiritide (Scios).

Issue Release: 2002

Treprostinil sodium Pharmacia.

Issue Release: 2002

The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology.

Issue Release: 2001

Alemtuzumab (Millennium/ILEX).

Issue Release: 2001

Special considerations concerning regulatory requirements and drug development for peptides and biotech products in the EU.

Issue Release: 1996

The validation of analytical methods for drug substances and drug products in UK pharmaceutical laboratories.

Issue Release: 1994

What are the Benefits of Collaborative Care Models?

Why is Medication Adherence Important?

Why is the Management of Chronic Conditions Important?

What is Pharma?

What is Geriatric Care in Pharma?

What Education and Training Do Pharmacists Need?

What are the Key Cellular Stress Pathways?

What is Medication Management?

What Challenges Exist in Patient Education?

What is the Future of Patient Education in Pharma?

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