Groups of experts and working parties under the EDQM
Would you like to contribute to quality assurance and standardisation of medicines in Europe? Then this information is relevant for you! This is a call for experts who have experience in methods of analysis of medicines or raw materials used in medicines and especially those who contribute to developing methods in their own lab.
Recruitment of experts
New members of groups of experts and working parties are to be nominated by the National Pharmacopoeia Authorities. Following nomination, the expert is to be approved by the European Pharmacopoeia Commission for nomination for a three-year period. The current period lapses at the end of November 2022 with the new period running from November 2022 to November 2025.
The Danish Medicines Agency is therefore looking for new candidates, experts and ad hoc specialists, to join the various groups of experts and working parties for the coming three-year period.
Read more at the website of the EDQM.
Submission of member nominations
Proposals for the appointment of members (experts and ad hoc specialists) to the various groups of experts and working parties must be submitted by email to the National Pharmacopoeia Authority of the Danish Medicines Agency by 3 October: Send e-mail.
The proposal must include a brief application letter and CV highlighting the qualifications relevant for the group(s)/party(ies) applied for. Information about the requested qualifications for the individual expert groups and working parties is provided in the "Terms of Reference and Profile for Members of Groups of Experts and Working Parties". The expert then receives the following relevant forms for completion:
- Declaration of Interest
- Nomination as expert / Nomination as ad hoc specialist
The work in the expert groups and working parties
There are 21 groups of experts and 39 working parties under the European Pharmacopoeia (Ph. Eur.). Their members are various national independent scientific experts and ad hoc specialists from national authorities (including official medicines control laboratories, licensing authorities and inspectors), the private sector (pharmaceutical, chemical or biological industries), universities and other research institutions. In addition to the members, a secretary from EDQM and representatives from the EDQM’s laboratory also participate. The groups and parties work with the elaboration and revision of the texts and monographs for the Ph. Eur. The groups of experts cover the general scientific aspects relevant for controlling the quality of medicines and the raw materials used. Many of the groups of experts therefore work with development and modernisation of analytical methods for quality control of medicines and raw materials.
Whereas the groups of experts are permanent, the working parties are appointed for a defined period to work in-depth with specific aspects or subjects related to the areas covered by the groups of experts. The contributions from the many groups of experts and working parties and the involvement of national experts are essential to the continued elaboration and revision of the Ph. Eur.
The amount of time to allocate for the expert work very much depends on the group of experts or working party being joined. The most active groups of experts usually hold 3 annual meetings of 1,5 days. The work volume in between meetings depends on the level of commitment to the group’s work. Expect to allocate time corresponding to at least 2 weeks’ work every year.
The 21 groups of experts and 39 working parties cover the following areas:
Group of Experts 1: Microbiology
Exp. gr. 6: Biological and Biotechnological products
Exp. gr. 6B: Human Plasma and Plasma Products
Exp. gr. 7: Antibiotics
Exp. gr. 9: Inorganic Chemistry
Exp. gr. 9G: Medicinal Gases
Exp. gr. 10A/B/C/D: Organic chemistry – synthetic and semi-synthetic products
Exp. gr. 11: Organic chemistry – natural, semi-synthetic and synthetic products
Exp. gr. 12: Dosage forms and pharmaceutical technical procedures
Exp. gr. 13A/B: Herbal Drugs and Herbal Drug Preparations
Exp. gr. 13H: Fatty oils and derivatives, polymers
Exp. gr. 14: Radiopharmaceutical Preparations
Exp. gr. 15: Human Vaccines and Sera
Exp. gr. 15V: Veterinary Vaccines and Sera
Exp. gr. 16: Plastic materials, plastic containers and closures
Exp. gr. 17: Medicinal products containing chemically defined active subst.
Exp. gr. P4: Single-source active substances, excipients and medicinal products with chemically defined active substances
ALG Working Party: Allergens
AQbD Working Party: Analytical quality by design
BACT Working Party: Bacteriophages
BET Working Party: Bacterial Endotoxin Test
BSR Working Party: Bovine serum
CE Working Party: Capillary Electrophoresis
CEL Working Party: Cellulose
COL Working Party: Colour determination
CRB Working Party: Carbohydrates
CST Working Party: Chromatographic separation techniques
CTP Working Party: Cell Therapy Products
DIA Working Party: Dialysis
EXP Working Party: Excipient performance
EXS Working Party: Excipient Strategy
GLS Working Party: Glass Containers
GTP Working Party: Gene Therapy Products
HM Working Party: Heavy metals
HMM Working Party: Homoeopathic Manufacturing Methods
HOM Working Party: Homoeopathic Raw Materials and Stocks
ICP Working Party: Inductively-Coupled Plasma
INH Working Party: Inhalations
MAB Working Party: Monoclonal Antibodies
MG Working Party: General methods
mRNAVAC Working Party: - mRNA Vaccines for human use
MYC Working Party: Mycoplasma
NBC Working Party: Non-Biological Complex Drugs
P4BIO Working Party: P4 Bio (Biologicals)
PaedF Working Party: European Paediatric Formulary
PAT Working Party: Process Analytical Technology
POW Working Party: Powder Characterisation
PRP Working Party: Precursors for Radiopharmaceutical Preparations
ROP Working Party: Rules of Procedure
SDA Working Party: Spectroscopy and Data Analysis
SIT Working Party: Second identification test
ST Working Party: Standard Terms
SUT Working Party: Sutures
TCM Working Party: Traditional Chinese Medicines
VIT Working Party: Vitamins
WAT Working Party: Water
On the website of the EDQM you can read more about the work carried out by the individual groups of experts and working parties.